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| ID | Type | Description | Link |
|---|---|---|---|
| PIP - 2018-002697-45 | |||
| U1111-1202-1096 | Other Identifier | UTN | |
| 2018-002697-45 | EudraCT Number |
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Study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met); not due to safety concerns.
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Primary Objective:
Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)
Secondary Objectives:
The study included:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia | Experimental | This arm includes participants from 3 cohorts: AML, T-ALL and B-ALL.; AML: Weekly dosing of isatuximab with induction chemotherapy. The therapy may be repeated one more cycle; ALL: (Includes T-ALL and B-ALL) Weekly dosing of isatuximab with induction chemotherapy, then biweekly dosing of isatuximab with consolidation chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isatuximab | Drug | Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: Intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) Rate | The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). | From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first. |
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Inclusion criteria:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute-Site Number:8400001 | Nashville | Tennessee | 37203 | United States | ||
| Children's Medical Center of Dallas-Site Number:8400002 |
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| Label | URL |
|---|---|
| ACT15378 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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The study consisted of a screening period (up to 3 weeks prior to the first study treatment administration), treatment period [Day 1 to Day 57 for Acute Lymphoblastic Leukemia(ALL); Day 1 to Day 22 for Acute Myeloid Leukemia(AML)],a period of aplasia followed by recovery period;an end of treatment (EOT) visit within 30 days after hematological recovery and a follow-up period.The study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met);not due to safety concerns.
This Phase II, open-label, single-arm study was conducted in 3 separate cohorts at 41 investigational sites in 16 countries. A total of 67 participants were enrolled between 06 Aug 2019 and 08 Jun 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | B-cell Acute Lymphoblastic Leukemia (B-ALL) | Participants with B-ALL received isatuximab 20 milligram per kilogram (mg/kg) intravenous (IV) infusion once every week (QW) for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and every 2 weeks (Q2W) during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| 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 | Oct 14, 2021 | Sep 1, 2023 |
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| Dexamethasone or equivalent | Drug | Pharmaceutical form: Solution for injection or tablet Route of administration: Intravenous or oral |
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| Fludarabine | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Cytarabine | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Liposomal daunorubicin | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Daunorubicin (nonliposomal) | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion |
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| Idarubicin | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Filgrastim or equivalent | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Mitoxantrone | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Doxorubicin | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Vincristine | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Pegaspargase (PEG) Asparaginase | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion |
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| Cyclophosphamide | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous |
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| Etoposide | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion |
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| Methotrexate | Drug | Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion |
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| L - Asparginase | Drug | Pharmaceutical form: Solution for injection Route of administration: Intramuscular |
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| Hydroxyurea | Drug | Pharmaceutical form: Solution for injection Route of administration: PO |
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| L - Asparaginase (Erwinase) | Drug | Pharmaceutical form: Solution for injection Route of administration: Intramuscular |
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| From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort) |
| Number of Participants With Infusion Reactions (IRs) | An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator. | From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort) |
| B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab | Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. | From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10 |
| AML: AUC of Isatuximab | Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. | From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8 |
| B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) | Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab. | Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57 |
| AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) | Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab. | Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15 |
| B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | At end of infusion on Cycle 1 Days 1 and 29 |
| AML: Ceoi of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | At end of infusion on Cycle 1 Days 1 and 15 |
| Number of Participants With Negative Minimal Residual Disease (MRD) | MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD. | From screening until the study completion date, approximately 45 months |
| Overall Response Rate (ORR) | ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: <5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC >=1000/mcL; platelets >100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant's underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). PR: >50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site. | From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks |
| Overall Survival (OS) | Overall survival was defined as the time interval from the date of first study treatment administration to death from any cause. It was estimated using the Kaplan-Meier method. Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley. | From first study treatment administration up to death due to any cause, a maximum of 45 months |
| Event-Free Survival (EFS) | EFS was defined as the time interval from the date of first study treatment administration to the date of the first of: completion or going off protocol induction/consolidation therapy without CR, relapse from CR, or death due to any cause, whichever occurred first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley. | From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months |
| Duration of Response (DoR) | Duration of response was defined as the time from the date of the first response to the date of first disease progression or death from any cause, whichever happens first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley. | From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months |
| Cluster of Differentiation (CD)38 Receptor Density | Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10^(Logarithm(Mean Fluorescence Intensity)*a+b) where "a" was the slope and "b" was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity [sABC]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control. | Pre-dose on Day 1 |
| CD38 Receptor Occupancy | Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100. | Pre-dose on Day 15 |
| Dallas |
| Texas |
| 75235 |
| United States |
| Investigational Site Number :0320002 | CABA | Buenos Aires | C1181ACH | Argentina |
| Investigational Site Number :0320006 | Capital Federal | Buenos Aires | C1425DUC | Argentina |
| Investigational Site Number :0320005 | Buenos Aires | C1118AAT | Argentina |
| Investigational Site Number :0320004 | Buenos Aires | C1245AAM | Argentina |
| Investigational Site Number :0760013 | Curitiba | Paraná | 80250-060 | Brazil |
| Investigational Site Number :0760006 | Curitiba | Paraná | 81520-060 | Brazil |
| Investigational Site Number :0760007 | Porto Alegre | Rio Grande do Sul | 90035 003 | Brazil |
| Investigational Site Number :0760010 | Jaú | São Paulo | 17210-070 | Brazil |
| Investigational Site Number :0760009 | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Investigational Site Number :0760001 | São Paulo | São Paulo | 08270-070 | Brazil |
| Investigational Site Number :0760004 | São Paulo | São Paulo | 4023-062 | Brazil |
| Investigational Site Number :2080001 | Copenhagen | 2100 | Denmark |
| Investigational Site Number :2500002 | Lille | 59037 | France |
| Investigational Site Number :2500003 | Lyon | 69008 | France |
| Investigational Site Number :2500001 | Paris | 75571 | France |
| Investigational Site Number :2500004 | Paris | 75935 | France |
| Investigational Site Number :2760005 | Erlangen | 91054 | Germany |
| Investigational Site Number :2760003 | Hamburg | 20246 | Germany |
| Investigational Site Number :2760006 | Münster | 48149 | Germany |
| Investigational Site Number :3000001 | Athens | 115 27 | Greece |
| Investigational Site Number :3480002 | Budapest | 1094 | Hungary |
| Investigational Site Number :3800002 | Genoa | Liguria | 16147 | Italy |
| Investigational Site Number :3800001 | Monza | Lombardy | 20900 | Italy |
| Investigational Site Number :3800003 | Turin | Piedmont | 10126 | Italy |
| Investigational Site Number :3800005 | Verona | Veneto | 37126 | Italy |
| Investigational Site Number :4840001 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number :4840005 | Col. Rancho Menchaca | Querétaro | 76140 | Mexico |
| Investigational Site Number :5280001 | Utrecht | 3584 CS | Netherlands |
| Investigational Site Number :5780001 | Bergen | 5021 | Norway |
| Investigational Site Number :5780002 | Oslo | 0342 | Norway |
| Investigational Site Number :6040001 | Arequipa | Peru |
| Investigational Site Number :6040002 | Lima | 34 | Peru |
| Investigational Site Number :6200002 | Coimbra | 3000-602 | Portugal |
| Investigational Site Number :6200001 | Lisbon | 1099-023 | Portugal |
| Investigational Site Number :6200003 | Porto | 4200-162 | Portugal |
| Investigational Site Number :4100001 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number :4100002 | Seoul | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number :4100004 | Seoul | Seoul-teukbyeolsi | 137-701 | South Korea |
| Investigational Site Number :7520001 | Gothenburg | 416 85 | Sweden |
| FG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| FG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| COMPLETED |
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| NOT COMPLETED |
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The All-treated (AT) population consisted of all participants who received at least 1 dose (even incomplete) of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | B-cell Acute Lymphoblastic Leukemia (B-ALL) | Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| BG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| BG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| BG003 | 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 | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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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 | Percentage of Participants With Complete Response (CR) Rate | The complete response rate (CR + CRi [complete response with incomplete peripheral recovery]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as <5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) >=1000/microliter (mcL); platelets >100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant's underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. | Posted | Number | percentage of participants | From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first. | The AT population consisted of all participants who received at least 1 dose (even incomplete) of study treatment. | Posted | Count of Participants | Participants | No | From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort) |
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| Secondary | Number of Participants With Infusion Reactions (IRs) | An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator. | The AT population consisted of all participants who received at least 1 dose (even incomplete) of study treatment. | Posted | Count of Participants | Participants | No | From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort) |
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| Secondary | B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab | Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. | The Pharmacokinetic (PK) population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | mg*hour (h)/Liter (L) | From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10 |
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| Secondary | AML: AUC of Isatuximab | Plasma samples were collected at specified timepoints to determine the AUC of isatuximab. | The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | mg*h/L | From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8 |
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| Secondary | B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) | Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab. | The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | microgram/milliliter (mcg/mL) | Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57 |
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| Secondary | AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough) | Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab. | The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | mcg/mL | Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15 |
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| Secondary | B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | mcg/mL | At end of infusion on Cycle 1 Days 1 and 29 |
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| Secondary | AML: Ceoi of Isatuximab | Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. | The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | mcg/mL | At end of infusion on Cycle 1 Days 1 and 15 |
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| Secondary | Number of Participants With Negative Minimal Residual Disease (MRD) | MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants who achieved CR/CRi were analyzed. | Posted | Count of Participants | Participants | No | From screening until the study completion date, approximately 45 months |
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| Secondary | Overall Response Rate (ORR) | ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: <5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC >=1000/mcL; platelets >100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant's underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC <1000/mcL or platelets <100000/mcL). PR: >50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. | Posted | Number | 80% Confidence Interval | percentage of participants | From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was defined as the time interval from the date of first study treatment administration to death from any cause. It was estimated using the Kaplan-Meier method. Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants with data available were analyzed. | Posted | Median | 95% Confidence Interval | months | From first study treatment administration up to death due to any cause, a maximum of 45 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) | EFS was defined as the time interval from the date of first study treatment administration to the date of the first of: completion or going off protocol induction/consolidation therapy without CR, relapse from CR, or death due to any cause, whichever occurred first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. | Posted | Median | 95% Confidence Interval | months | From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | Duration of response was defined as the time from the date of the first response to the date of first disease progression or death from any cause, whichever happens first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only responders were included in this analysis. | Posted | Median | 95% Confidence Interval | months | From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Cluster of Differentiation (CD)38 Receptor Density | Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10^(Logarithm(Mean Fluorescence Intensity)*a+b) where "a" was the slope and "b" was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity [sABC]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | sABC | Pre-dose on Day 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | CD38 Receptor Occupancy | Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = [(sABC MAb2 - sABC MAb1)/sABC MAb2] X 100. | The evaluable population consisted of evaluable participants from the AT population who received at least 1 full dose of isatuximab in Cycle 1 and who had at least 1 valid response value that was evaluable. Only those participants with data available at specified timepoints were analyzed. | Posted | Mean | Standard Deviation | percent receptor occupancy | Pre-dose on Day 15 |
|
TEAEs were collected from the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort). All-cause mortality (Deaths) was collected for the entire study duration, a maximum of 45 months
Analysis was performed on the AT population.
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 | B-cell Acute Lymphoblastic Leukemia (B-ALL) | Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. | 17 | 27 | 19 | 27 | 26 | 27 |
| EG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. | 8 | 13 | 12 | 13 | 12 | 13 |
| EG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. | 18 | 27 | 17 | 27 | 24 | 27 |
| EG003 | All Participants | All participants in the study were included in this cohort. | 43 | 67 | 48 | 67 | 62 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Bacterial Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Disseminated Aspergillosis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Fournier's Gangrene | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Fungal Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Genital Herpes Zoster | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pseudomonal Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Sinusitis Fungal | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Febrile Bone Marrow Aplasia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Anaphylactic Shock | Immune system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haemophagocytic Lymphohistiocytosis | Immune system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDra 26.0 | Systematic Assessment |
| |
| Aortic Aneurysm | Vascular disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Mouth Haemorrhage | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neutropenic Colitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Lip Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Viral Rhinitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Eyelid Oedema | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDra 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra 26.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Anal Inflammation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Nephropathy Toxic | Renal and urinary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Renal Tubular Necrosis | Renal and urinary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Face Oedema | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDra 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
|
The study was prematurely stopped due to sponsor decision (stage 2 efficacy criteria not met) and not due to safety concerns.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2022 | Sep 1, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| 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 |
| D007951 | Leukemia, Myeloid |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599209 | isatuximab |
| D003907 | Dexamethasone |
| C024352 | fludarabine |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| D015255 | Idarubicin |
| D000069585 | Filgrastim |
| D008942 | Mitoxantrone |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| C042705 | pegaspargase |
| D001215 | Asparaginase |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008727 | Methotrexate |
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| 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 |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D014508 | Urea |
| D000577 | Amides |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
|
|
Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
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Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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| OG001 | T-cell Acute Lymphoblastic Leukemia (T-ALL) | Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
| OG002 | Acute Myeloid Leukemia (AML) | Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first. |
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