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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003377-34 | EudraCT Number | ||
| 54767414ALL2005 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
Screening for eligible participants will be performed within 21 days before administration of the study drug. Participants with B-cell ALL/LL will receive treatment until disease progression, unacceptable toxicity or achievement of CR followed by hematopoietic stem cell transplant (HSCT). Participants with T cell ALL/LL will receive treatment for up to 2 cycles. If disease progression is confirmed, then the participant will discontinue study treatment, complete the End of Treatment Visit, and enter the Posttreatment Period. For those participants who discontinue study drug prior to disease progression, disease evaluations will continue to be performed every 8 weeks until subsequent anticancer therapy is initiated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: B-Cell Acute Lymphoblastic Leukemia (ALL)/LL | Experimental | Cohort 1 will include participants with B cell ALL/LL in second or greater relapse or refractory to at least 2 prior induction regimens. Participant will receive daratumumab in combination with vincristine and prednisone. |
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| Cohort 2: T-Cell ALL/LL | Experimental | Cohort 2 will include participants with T-cell ALL/LL in first relapse or refractory to at least 1 prior induction/consolidation regimen. Participant will receive daratumumab in combination with vincristine, prednisone, doxorubicin and peg-asparaginase in Cycle 1 and daratumumab in combination with cyclophosphamide, cytarabine, 6- mercaptopurine and methotrexate in Cycle 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL) | Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (>)100*10^9 cells/liter (L) and absolute neutrophil count (ANC) >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arm only. | Up to 2 cycles, that is, up to 56 days (each cycle of 28-days) |
| Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL | Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arms only. | End of Cycle 1 (that is, up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of >=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions. |
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Inclusion Criteria:
Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) as defined by the criteria below:
Performance status greater than or equal to (>=) 70 by Lansky scale (for participants less than [<] 16 years of age) or Karnofsky scale (for participants [>=] 16 years of age)
Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing defined as follows:
Adequate renal function defined as normal serum creatinine for the participant's age or creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) prior to enrollment
Adequate liver function prior to enrollment defined as:
Exclusion Criteria:
Received an allogeneic hematopoietic transplant within 3 months of screening
Active acute graft-versus-host disease of any grade or chronic graft-versus-host disease of Grade 2 or higher
Received immunosuppression post hematopoietic transplant within 1 month of study entry
Philadelphia chromosome positive (Ph+) B-cell ALL eligible for tyrosine kinase inhibitor therapy
Has either of the following:
Received an investigational drug, was vaccinated with live attenuated vaccines, or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug, or is currently being treated in an investigational study
Known to be seropositive for human immunodeficiency virus (HIV)
Any one of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233-1711 | United States | ||
| Phoenix Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39158071 | Derived | Bhatla T, Hogan LE, Teachey DT, Bautista F, Moppett J, Velasco Puyo P, Micalizzi C, Rossig C, Shukla N, Gilad G, Locatelli F, Baruchel A, Zwaan CM, Bezler NS, Rubio-San-Simon A, Taussig DC, Raetz EA, Mao ZJ, Wood BL, Alvarez Arias D, Krevvata M, Nnane I, Bandyopadhyay N, Lopez Solano L, Dennis RM, Carson R, Vora A. Daratumumab in pediatric relapsed/refractory acute lymphoblastic leukemia or lymphoblastic lymphoma: the DELPHINUS study. Blood. 2024 Nov 21;144(21):2237-2247. doi: 10.1182/blood.2024024493. | |
| 33245179 |
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After enrollment of 47 participants, one participant in Cohort 1: B-cell acute lymphoblastic leukemia (ALL) (1-17 Years) was withdrawn prior to receiving treatment, and thus only 46 participants were treated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: B-cell ALL (1-17 Years) | Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (<) 2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: greater than or equal to (>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2019 | Sep 20, 2023 |
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| Vincristine | Drug | Participant will receive vincristine 1.5 milligram per meter square (mg/m^2) in cohort 1 and cohort 2. |
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| Prednisone | Drug | Participant will receive prednisone 40 mg/m^2 in cohort 1 and cohort 2. |
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| Doxorubicin | Drug | Participant will receive doxorubicin 60 mg/m^2 in cohort 2. |
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| Peg-asparaginase | Biological | Participant will receive peg-asparaginase 2500 units per meter square (U/m^2) in cohort 2. |
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| Cyclophosphamide | Drug | Participant will receive cyclophosphamide 1 gram per meter square (g/m^2) once in cohort 2. |
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| Cytarabine | Drug | Participant will receive cytarabine 75 mg/m^2 in cohort 2. |
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| 6-mercaptopurine | Drug | Participant will receive 6-mercaptopurine 60 mg/m^2 orally daily in cohort 2. |
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| Methotrexate | Drug | Participant will receive methotrexate 5 g/m^2 intravenously (IV) in cohort 2. |
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| Up to 4 years 4 months |
| Event-free Survival (EFS) | EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is [ie], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis. | Up to 4 years 4 months |
| Relapse-free Survival (RFS) | RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis. | Up to 4 years 4 months |
| Overall Survival (OS) | OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event. | Up to 4 years 4 months |
| Minimal Residual Disease (MRD) Negative Rate | MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry. | Up to 4 years 4 months |
| Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported. | Up to 4 years 4 months |
| Maximum Observed Serum Concentration (Cmax) of Daratumumab | Cmax was defined as maximum observed serum concentration of daratumumab. | Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2 |
| Minimum Observed Serum Concentration (Cmin) of Daratumumab | Cmin was defined as minimum observed serum concentration of daratumumab. | Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2 |
| Number of Participants With Anti-daratumumab Antibodies | Number of participants with anti-daratumumab antibodies was reported. | Up to 4 years 4 months |
| Concentration of Daratumumab in Cerebrospinal Fluid (CSF) | Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
| Children's Hospital Orange County | Orange | California | 92868 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics | Atlanta | Georgia | 30342 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21231-1000 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215-5418 | United States |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109-4257 | United States |
| Washington Univeristy School of Medicine/ Pediatrics | St Louis | Missouri | 63110 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11733 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43214 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center | Austin | Texas | 78723 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Utah Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226-3522 | United States |
| Universitair Ziekenhuis Gent - UZ GENT | Ghent | 9000 | Belgium |
| CHU de Bordeaux, Hopital des Enfants | Bordeaux | 33076 | France |
| IHOPE - Hospices civils de Lyon | Lyon | 69008 | France |
| Hopital trousseau- APHP | Paris | 75012 | France |
| Hôpital Robert Debré | Paris | 75019 | France |
| Hôpital D'Enfants | Vandœuvre-lès-Nancy | 54500 | France |
| Charite-Universitätsmedizin Berlin - Berlin | Berlin | 13353 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Schneider Children's Medical Center | Petach Tiquva | 4920235 | Israel |
| Istituto Giannina Gaslini | Genova | 16147 | Italy |
| Fondazione MBBM, ASST Monza | Monza | 20900 | Italy |
| Ospedale Pediatrico Bambin Gesù | Roma | 00165 | Italy |
| AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita | Torino | 10126 | Italy |
| Princess Maxima Center | Utrecht | 3584 EA | Netherlands |
| Hosp Univ Vall D Hebron | Barcelona | 8035 | Spain |
| Hosp. Sant Joan de Deu | Esplugues de Llobregat | 08950 | Spain |
| Hosp. Infantil Univ. Nino Jesus | Madrid | 28009 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| Bristol Royal Hospital for Children | Bristol | BS2 8BJ | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | G51 4TF | United Kingdom |
| Leeds Children's Hospital | Leeds | LS1 3EX | United Kingdom |
| University College London Hospitals | London | NW1 2BU | United Kingdom |
| Great Ormond Street Hospital | London | WC1N 2JH | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
| Royal Marsden Hospital | Surrey | SM2 5PT | United Kingdom |
| Derived |
| Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature. Pediatr Blood Cancer. 2021 May;68(5):e28829. doi: 10.1002/pbc.28829. Epub 2020 Nov 27. No abstract available. |
| FG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| FG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| FG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: B-cell ALL (1-17 Years) | Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (<) 2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: greater than or equal to (>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months). |
| BG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| BG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| BG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL) | Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (>)100*10^9 cells/liter (L) and absolute neutrophil count (ANC) >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arm only. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Number | 90% Confidence Interval | Percentage of participants | Up to 2 cycles, that is, up to 56 days (each cycle of 28-days) |
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| Primary | Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL | Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arms only. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Number | 90% Confidence Interval | Percentage of participants | End of Cycle 1 (that is, up to 28 days) |
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| Secondary | Overall Response Rate (ORR) | For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of >=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Number | 90% Confidence Interval | Percentage of participants | Up to 4 years 4 months |
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| Secondary | Event-free Survival (EFS) | EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is [ie], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Median | 90% Confidence Interval | Months | Up to 4 years 4 months |
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| Secondary | Relapse-free Survival (RFS) | RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis. | The response evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and had at least 1 adequate post-baseline disease assessment. Here, 'N' (number of participants analysed) signifies all treated participants who achieved a complete response. | Posted | Median | 90% Confidence Interval | Months | Up to 4 years 4 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Median | 90% Confidence Interval | Months | Up to 4 years 4 months |
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| Secondary | Minimal Residual Disease (MRD) Negative Rate | MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Number | 90% Confidence Interval | Percentage of participants | Up to 4 years 4 months |
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| Secondary | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported. | The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab. | Posted | Number | 90% Confidence Interval | Percentage of participants | Up to 4 years 4 months |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Daratumumab | Cmax was defined as maximum observed serum concentration of daratumumab. | The serum pharmacokinetics (PK) evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion blood sample for serum daratumumab concentrations. | Posted | Mean | Standard Deviation | Micrograms per milliliter (mcg/mL) | Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2 |
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| Secondary | Minimum Observed Serum Concentration (Cmin) of Daratumumab | Cmin was defined as minimum observed serum concentration of daratumumab. | The serum PK evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion blood sample for serum daratumumab concentrations. | Posted | Mean | Standard Deviation | mcg/mL | Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2 |
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| Secondary | Number of Participants With Anti-daratumumab Antibodies | Number of participants with anti-daratumumab antibodies was reported. | The immunogenicity evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and had at least 1 post-infusion sample for detection of anti-daratumumab antibodies. | Posted | Count of Participants | Participants | Up to 4 years 4 months |
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| Secondary | Concentration of Daratumumab in Cerebrospinal Fluid (CSF) | Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. | The CSF PK evaluable analysis set included all enrolled participants who received at least 1 dose of daratumumab and provided at least 1 post-infusion CSF sample for daratumumab concentrations. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represent number of participants evaluable for specified timepoints. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15 |
|
From baseline (Day 1) up to 4 years 4 months
The safety analysis set included all enrolled participants who received at least 1 dose of daratumumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: B-cell ALL (1-17 Years) | Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (<) 2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: greater than or equal to (>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months). | 7 | 7 | 3 | 7 | 7 | 7 |
| EG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). | 14 | 24 | 16 | 24 | 24 | 24 |
| EG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). | 3 | 5 | 4 | 5 | 5 | 5 |
| EG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). | 8 | 10 | 7 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Campylobacter Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Enterobacter Bacteraemia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mucormycosis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pseudomonas Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Blood Lactic Acid Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pseudomonas Test Positive | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Staphylococcus Test Positive | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Brain Oedema | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Depressed Level of Consciousness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Peripheral Nerve Palsy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Posterior Reversible Encephalopathy Syndrome | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Psychotic Disorder | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Pharyngeal Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypocoagulable State | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymph Node Pain | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Adrenal Insufficiency | Endocrine disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Eye Oedema | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Eye Pruritus | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Anal Fistula | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anal Inflammation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Gingival Bleeding | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lip Dry | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tongue Coated | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Catheter Site Haematoma | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Localised Oedema | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vascular Device Occlusion | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hepatic Cytolysis | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Splenic Infection Fungal | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Wound Complication | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ammonia Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Antithrombin Iii Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Fibrinogen Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT Prolonged | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Interleukin Level Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urine Output Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperferritinaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Depressed Level of Consciousness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Device Occlusion | Product Issues | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Renal Tubular Disorder | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Allergic Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasal Mucosal Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pharyngeal Enanthema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Skin Striae | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Menopause | Social circumstances | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Superficial Vein Thrombosis | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head | Janssen-Cilag International NV | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2022 | Sep 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C556306 | daratumumab |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D004317 | Doxorubicin |
| C042705 | pegaspargase |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D015122 | Mercaptopurine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| FRANCE |
|
| GERMANY |
|
| ISRAEL |
|
| ITALY |
|
| NETHERLANDS |
|
| SPAIN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| OG001 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG002 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
|
|
| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
|
|
| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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| OG001 | Cohort 2: T-Cell ALL (1-17 Years) | Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV infusion once on Day 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide IV 1 g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months). |
| OG002 | Cohort 2: T-Cell ALL (18-30 Years) | Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months). |
| OG003 | Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years) | Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg: >=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m^2 as 2 doses (20 mg/m^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to <2 years, 10 mg: 2 to <3 years, 12 mg: 3 to <9 years and 15 mg:>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m^2 as IV once on Day 2, cyclophosphamide 1g/m^2 once on Day 15; cytarabine 75 mg/m^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months). |
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