Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
Phase 3
Active, not recruiting
NCT02112916
| Condition | Adult T Acute Lymphoblastic Leukemia, Ann Arbor Stage II Adult Lymphoblastic Lymphoma, Ann Arbor Stage II Childhood Lymphoblastic Lymphoma, Ann Arbor Stage III Adult Lymphoblastic Lymphoma |
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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 | 847 participants |
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| Interventions | Bortezomib, Cyclophosphamide, Cytarabine, Daunorubicin, Daunorubicin Hydrochloride |
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| Start date | Oct 4, 2014 |
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| Completion date | Mar 31, 2020 |
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| Results posted | Feb 23, 2022 |
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Summary
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
3 years · Percentage of participants
| Arm A (Combination Chemotherapy) | 81.7 Percentage of participants |
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| Arm B (Combination Chemotherapy, Bortezomib) | 85.1 Percentage of participants |
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| p-value | 0.074 |
| Hazard Ratio (HR) | 0.782 (95% CI 0.561–1.091) |
Open in BENITIONS
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