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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000536-10 | EudraCT Number |
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The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.
Adults with relapsed/refractory B-cell precursor ALL were randomized in a 2:1 ratio to receive blinatumomab or 1 of 4 pre-specified, investigator-chosen, SOC chemotherapy regimens. Randomization was stratified by age (< 35 years vs ≥ 35 years of age), prior salvage therapy (yes vs no), and prior allogeneic HSCT (yes vs no) as assessed at the time of consent.
The study consisted of up to a 3-week screening and pre-phase period, a treatment period consisting of induction with 2 cycles of either blinatumomab or SOC chemotherapy, a consolidation phase of up to 3 additional cycles of protocol-specified therapy, and a maintenance phase for up to an additional 12 months with protocol-specified therapy. A safety follow-up visit 30 days after the last dose of protocol-specified therapy and a long-term follow-up period were included. The long-term follow-up part of the study was discontinued prematurely based on a recommendation from the data monitoring committee (DMC) that the study be stopped for benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinatumomab | Experimental | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
|
| Standard of Care Chemotherapy | Active Comparator | Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab is administered as a continuous intravenous infusion (CIV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. | From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy. |
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Subjects with Philadelphia negative B-precursor ALL, with any of the following:
Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
Greater than 5% blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28631497 | Background | Delea TE, Amdahl J, Boyko D, Hagiwara M, Zimmerman ZF, Franklin JL, Cong Z, Hechmati G, Stein A. Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative B-precursor acute lymphoblastic leukemia from a US payer perspective. J Med Econ. 2017 Sep;20(9):911-922. doi: 10.1080/13696998.2017.1344127. Epub 2017 Jul 11. | |
| 28249141 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were randomized in a 2:1 ratio to either blinatumomab or standard of care (SOC) chemotherapy regimens. Randomization was stratified by age (< 35 years vs ≥ 35 years), prior salvage therapy (yes vs no), and prior allogeneic hematopoietic stem cell transplantation (HSCT) (yes vs no) as assessed at the time of consent.
This study was conducted at 101 centers in 21 countries in Asia, Australia, Europe, and Latin and North America.
The first participant was enrolled on 03 January 2014 and treated on 06 January 2014. The last participant enrolled on 25 September 2015 and the data cutoff date for this report was 04 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Chemotherapy | Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard of Care Chemotherapy | Drug |
|
|
| 12 weeks |
| Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and ANC > 1,000/μl. Complete Remission with partial hematological recovery (CRh*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl. Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000 (but not both). | 12 weeks |
| Event Free Survival (EFS) | Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date. A relapse event was any one of the following:
The Kaplan-Meier estimate of EFS at 6 months is reported. | 6 months |
| Duration of Complete Remission | Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date. | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group. |
| Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) | Duration of CR/CRh*/CRi, calculated only for participants who achieved a CR/CRh*/CRi, was calculated from the date a CR/CRh*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date. | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group. |
| Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation | Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry. | 12 weeks |
| Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months. |
| Number of Participants With Adverse Events | Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures? | From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group. |
| 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant | The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. | 100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016 |
| Number of Participants With Anti-blinatumomab Antibodies | Anti-blinatumomab binding antibodies were evaluated using a validated electrochemiluminescence (ECL)-based assay (binding assay). Samples positive for binding were analyzed using a cell-based bioassay to determine if the detected antibodies had neutralizing properties (neutralizing assay). | Samples were collected on day 29 at the end of cycle 2 and 30 days after the last dose of blinatumomab (median duration of treatment was 70 days). |
| Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item questionnaire that assesses the health related quality of life of cancer patients. The EORTC QLQ-C30 consists of a global health status/quality of life (QoL) scale, 5 functional scales, 3 symptom scales, and 6 single items. The global health/QoL scale consists of 2 questions that ask participants to rate their overall health and overall quality of life durig the past week on a scale from 1 (very poor) to 7 (excellent). The scale score was derived as the sum of each score and transformed to a scale from 0 to 100 where higher scores represent a high QoL. Time to a ≥10-point decrease from baseline GHS/QoL or death, whichever came first, was calculated from baseline. Participants still alive and without a 10-point decrease in GHS/QoL EORTC QLQ-C30 were censored on their last EORTC QLQ-C30 assessment date. | From randomization until the data cut-off date of 04 January 2016; EORTC QLQ-C30 was assessed on day 1, 8, 15, and 29 during cycle 1; days 1, 15, and 29 in cycle 2 and each consolidation cycle, and 30-days following the last dose of drug treatment. |
| Los Angeles |
| California |
| 90095 |
| United States |
| Research Site | San Francisco | California | 94143 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Chicago | Illinois | 60637 | United States |
| Research Site | Baltimore | Maryland | 21201 | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | St Leonards | New South Wales | 2065 | Australia |
| Research Site | Herston | Queensland | 4029 | Australia |
| Research Site | Adelaide | South Australia | 5000 | Australia |
| Research Site | Parkville | Victoria | 3050 | Australia |
| Research Site | Prahran | Victoria | 3181 | Australia |
| Research Site | Murdoch | Western Australia | 6150 | Australia |
| Research Site | Salzburg | 5020 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vienna | 1140 | Austria |
| Research Site | Wels | 4600 | Austria |
| Research Site | Antwerp | 2060 | Belgium |
| Research Site | Bruges | 8000 | Belgium |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Yvoir | 5530 | Belgium |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Sofia | 1756 | Bulgaria |
| Research Site | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Montreal | Quebec | H1T 2M4 | Canada |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Prague | 128 20 | Czechia |
| Research Site | Créteil | 94010 | France |
| Research Site | Le Chesnay | 78157 | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Paris | 75475 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Berlin | 12200 | Germany |
| Research Site | Cologne | 50937 | Germany |
| Research Site | Essen | 45147 | Germany |
| Research Site | Frankfurt am Main | 60590 | Germany |
| Research Site | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Kiel | 24116 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | München | 81377 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Tübingen | 72076 | Germany |
| Research Site | Ulm | 89081 | Germany |
| Research Site | Würzburg | 97080 | Germany |
| Research Site | Athens | 10676 | Greece |
| Research Site | Athens | 11527 | Greece |
| Research Site | Ioannina | 45110 | Greece |
| Research Site | Pátrai | 26500 | Greece |
| Research Site | Thessaloniki | 57010 | Greece |
| Research Site | Dublin | 8 | Ireland |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Jerusalem | 91031 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Tel Aviv | 64239 | Israel |
| Research Site | Tel Litwinsky | 52621 | Israel |
| Research Site | Bari | 70124 | Italy |
| Research Site | Bergamo | 24127 | Italy |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Florence | 50134 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Novara | 28100 | Italy |
| Research Site | Palermo | 90146 | Italy |
| Research Site | Roma | 00133 | Italy |
| Research Site | Roma | 00161 | Italy |
| Research Site | Torino | 10126 | Italy |
| Research Site | Venezia | 30174 | Italy |
| Research Site | Verona | 37134 | Italy |
| Research Site | Mexico City | Mexico City | 07760 | Mexico |
| Research Site | Monterrey | Nuevo León | 64460 | Mexico |
| Research Site | Lublin | 20-081 | Poland |
| Research Site | Warsaw | 02-776 | Poland |
| Research Site | Warsaw | 04-141 | Poland |
| Research Site | Wroclaw | 50-367 | Poland |
| Research Site | Moscow | 125167 | Russia |
| Research Site | Nizhny Novgorod | 603126 | Russia |
| Research Site | Petrozavodsk | 185019 | Russia |
| Research Site | Saratov | 410012 | Russia |
| Research Site | Busan | 614-735 | South Korea |
| Research Site | Seoul | 110-744 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Seoul | 138-736 | South Korea |
| Research Site | Salamanca | Castille and León | 37007 | Spain |
| Research Site | Badalona | Catalonia | 08916 | Spain |
| Research Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Research Site | Valencia | Valencia | 46026 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Changhua | 50006 | Taiwan |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Adana | 01330 | Turkey (Türkiye) |
| Research Site | Ankara | 06100 | Turkey (Türkiye) |
| Research Site | Istanbul | 34093 | Turkey (Türkiye) |
| Research Site | Izmir | 35340 | Turkey (Türkiye) |
| Research Site | Bristol | BS2 8ED | United Kingdom |
| Research Site | London | NW3 2PF | United Kingdom |
| Research Site | Oxford | OX3 7LJ | United Kingdom |
| Research Site | Sheffield | S10 2JF | United Kingdom |
| Research Site | Southampton | SO16 6YD | United Kingdom |
| Research Site | Sutton | SM2 5PT | United Kingdom |
| Background |
| Kantarjian H, Stein A, Gokbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foa R, Bassan R, Arslan O, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Bruggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783. |
| 30947585 | Background | Dombret H, Topp MS, Schuh AC, Wei AH, Durrant S, Bacon CL, Tran Q, Zimmerman Z, Kantarjian H. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019 Sep;60(9):2214-2222. doi: 10.1080/10428194.2019.1576872. Epub 2019 Apr 5. |
| 30645768 | Background | Kuchimanchi M, Zhu M, Clements JD, Doshi S. Exposure-response analysis of blinatumomab in patients with relapsed/refractory acute lymphoblastic leukaemia and comparison with standard of care chemotherapy. Br J Clin Pharmacol. 2019 Apr;85(4):807-817. doi: 10.1111/bcp.13864. Epub 2019 Feb 18. |
| 29954814 | Background | Stein AS, Larson RA, Schuh AC, Stevenson W, Lech-Maranda E, Tran Q, Zimmerman Z, Kormany W, Topp MS. Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia. Blood Adv. 2018 Jul 10;2(13):1522-1531. doi: 10.1182/bloodadvances.2018019034. |
| 29739753 | Background | Topp MS, Zimmerman Z, Cannell P, Dombret H, Maertens J, Stein A, Franklin J, Tran Q, Cong Z, Schuh AC. Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. Blood. 2018 Jun 28;131(26):2906-2914. doi: 10.1182/blood-2017-09-804658. Epub 2018 May 8. |
| 34830762 | Background | Kantarjian HM, Zugmaier G, Bruggemann M, Wood BL, Horst HA, Zeng Y, Martinelli G. Impact of Blinatumomab Treatment on Bone Marrow Function in Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia. Cancers (Basel). 2021 Nov 9;13(22):5607. doi: 10.3390/cancers13225607. |
| 37345570 | Background | Horst HA, Zugmaier G, Martinelli G, Mergen N, Velasco K, Zaman F, Kantarjian H. CD19-negative relapse in adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia following treatment with blinatumomab-a post hoc analysis. Am J Hematol. 2023 Aug;98(8):E222-E225. doi: 10.1002/ajh.26988. Epub 2023 Jun 22. No abstract available. |
| 35622074 | Derived | Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704. |
| 34161631 | Derived | Jabbour E, Patel K, Jain N, Duose D, Luthra R, Short NJ, Zugmaier G, San Lucas A, Velasco K, Tran Q, Zaman F, Konopleva M, Kantarjian H. Impact of Philadelphia chromosome-like alterations on efficacy and safety of blinatumomab in adults with relapsed/refractory acute lymphoblastic leukemia: A post hoc analysis from the phase 3 TOWER study. Am J Hematol. 2021 Oct 1;96(10):E379-E383. doi: 10.1002/ajh.26281. Epub 2021 Jul 7. No abstract available. |
| 33542479 | Derived | Wei AH, Ribera JM, Larson RA, Ritchie D, Ghobadi A, Chen Y, Anderson A, Dos Santos CE, Franklin J, Kantarjian H. Biomarkers associated with blinatumomab outcomes in acute lymphoblastic leukemia. Leukemia. 2021 Aug;35(8):2220-2231. doi: 10.1038/s41375-020-01089-x. Epub 2021 Feb 4. |
| 32289160 | Derived | Rambaldi A, Huguet F, Zak P, Cannell P, Tran Q, Franklin J, Topp MS. Blinatumomab consolidation and maintenance therapy in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia. Blood Adv. 2020 Apr 14;4(7):1518-1525. doi: 10.1182/bloodadvances.2019000874. |
| FG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Chemotherapy | Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months. |
| BG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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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| Age, Customized | Number | participants |
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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/Ethnicity, Customized | Number | participants |
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| Age Stratification at Randomization | Number | participants |
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| Prior Salvage Therapy Stratification at Randomization | Number | participants |
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| Prior Allogeneic Hematopoietic Stem Cell Transplant (HCST) | Number | participants |
| ||||||||||||||||
| Standard of Care Chemotherapy Regimen Received | FLAG = fludarabine, cytarabine arabinoside, and granulocyte colony-stimulating factor (filgrastim); HiDAC = high-dose cytarabine arabinoside | Number | participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival | Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. | All randomized participants | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group. |
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| Secondary | Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
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| Secondary | Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and ANC > 1,000/μl. Complete Remission with partial hematological recovery (CRh*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl. Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000 (but not both). | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
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| Secondary | Event Free Survival (EFS) | Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date. A relapse event was any one of the following:
The Kaplan-Meier estimate of EFS at 6 months is reported. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Duration of Complete Remission | Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date. | Randomized participants with a best response of complete remission within 12 weeks of treatment initiation. | Posted | Median | 95% Confidence Interval | months | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group. |
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| Secondary | Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) | Duration of CR/CRh*/CRi, calculated only for participants who achieved a CR/CRh*/CRi, was calculated from the date a CR/CRh*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date. | Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation. | Posted | Median | 95% Confidence Interval | months | Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group. |
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| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation | Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
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| Secondary | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months. |
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| Secondary | Number of Participants With Adverse Events | Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures? | All participants who received protocol-specified therapy analyzed according to the treatment they received. | Posted | Number | participants | From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group. |
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| Secondary | 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant | The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. | Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation and who received an allogeneic HSC without anti-cancer therapy prior to allogeneic HSCT. | Posted | Number | 95% Confidence Interval | percentage of participants | 100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016 |
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| Secondary | Number of Participants With Anti-blinatumomab Antibodies | Anti-blinatumomab binding antibodies were evaluated using a validated electrochemiluminescence (ECL)-based assay (binding assay). Samples positive for binding were analyzed using a cell-based bioassay to determine if the detected antibodies had neutralizing properties (neutralizing assay). | Participants who received blinatumomab with available post-baseline antibody data. | Posted | Number | participants | Samples were collected on day 29 at the end of cycle 2 and 30 days after the last dose of blinatumomab (median duration of treatment was 70 days). |
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| Secondary | Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item questionnaire that assesses the health related quality of life of cancer patients. The EORTC QLQ-C30 consists of a global health status/quality of life (QoL) scale, 5 functional scales, 3 symptom scales, and 6 single items. The global health/QoL scale consists of 2 questions that ask participants to rate their overall health and overall quality of life durig the past week on a scale from 1 (very poor) to 7 (excellent). The scale score was derived as the sum of each score and transformed to a scale from 0 to 100 where higher scores represent a high QoL. Time to a ≥10-point decrease from baseline GHS/QoL or death, whichever came first, was calculated from baseline. Participants still alive and without a 10-point decrease in GHS/QoL EORTC QLQ-C30 were censored on their last EORTC QLQ-C30 assessment date. | EORTC QLQ-C30 analysis set included all randomized participants with a non-missing baseline and at least 1 non-missing postbaseline result of any EORTC QLQ-C30 scales/item. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 04 January 2016; EORTC QLQ-C30 was assessed on day 1, 8, 15, and 29 during cycle 1; days 1, 15, and 29 in cycle 2 and each consolidation cycle, and 30-days following the last dose of drug treatment. |
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From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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 | Standard of Care Chemotherapy | Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive SOC therapy for an additional 12 months. | 49 | 109 | 105 | 109 | ||
| EG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. | 165 | 267 | 250 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aplasia | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute graft versus host disease in skin | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Graft versus host disease in liver | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abscess fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Central nervous system abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Citrobacter infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Citrobacter sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalitis enteroviral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fusarium infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatosplenic candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infection in an immunocompromised host | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Mucormycosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| CSF cell count abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Leukaemic infiltration extramedullary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Leukaemic infiltration pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemianopia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intention tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Catheter placement | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic occlusion | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| 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 |
|---|---|
| C510808 | blinatumomab |
Not provided
Not provided
Not provided
| 35 to 54 years |
|
| 55 to 64 years |
|
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Multiple |
|
| Other |
|
| ≥ 35 years |
|
| No |
|
| No |
|
| High-dose methotrexate |
|
| Clofarabine |
|
| HIDAC |
|
|
|
|
| OG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
|
|
|
| OG001 |
| Blinatumomab |
Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
|
|
| OG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Blinatumomab | Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles. |
|
|