Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia
Phase 3
Active, not recruiting
NCT02101853
| Condition | Recurrent B Acute Lymphoblastic Leukemia |
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| Phase | Phase 3 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 669 participants |
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| Interventions | Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase, Blinatumomab, Cyclophosphamide, Cytarabine |
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| Start date | Dec 17, 2014 |
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| Completion date | Jun 30, 2021 |
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| Results posted | Dec 6, 2022 |
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Summary
This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.
Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients
Up to 2 years from date of randomization · percentage of participants
| Arm A (HR and IR Control) | 39.04 percentage of participants |
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| Arm B (HR and IR Blinatumomab) | 54.44 percentage of participants |
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Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
Up to 3 years from date of randomization · percentage of participants
| Arm C (LR Control) | 58.94 percentage of participants |
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| Arm D (LR Blinatumomab) | 67.00 percentage of participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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