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
3期
进行中(已停止招募)
NCT02112916
| 适应症 | 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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| 分期 | 3期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 847 人 |
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| 干预(药物) | Bortezomib, Cyclophosphamide, Cytarabine, Daunorubicin, Daunorubicin Hydrochloride |
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| 开始日期 | 2014年10月4日 |
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| 完成日期 | 2020年3月31日 |
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| 结果公布日 | 2022年2月23日 |
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摘要
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) |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。