Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
Phase 3
Active, not recruiting
NCT02003222
| Condition | Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative |
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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 | 488 participants |
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| Interventions | Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Blinatumomab, Bone Marrow Aspiration, Bone Marrow Biopsy |
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| Start date | May 19, 2014 |
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| Completion date | Jun 23, 2023 |
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| Results posted | Sep 24, 2024 |
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Summary
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years · months
| MRD Negative - Blinatumomab + Chemotherapy | NA months |
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| MRD Negative - Chemotherapy | NA months |
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| p-value | 0.003 |
| Hazard Ratio (HR) | 0.44 (95% CI 0.25–0.76) |
Open in BENITIONS
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