Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
3期
进行中(已停止招募)
NCT02048813
| 适应症 | Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic 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 | 529 人 |
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| 干预(药物) | Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study |
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| 开始日期 | 2014年3月10日 |
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| 完成日期 | 2018年10月24日 |
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| 结果公布日 | 2023年8月14日 |
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摘要
This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
Progression-free Survival (PFS) Rate at 3 Years
Assessed every 3 months until progression up to 4 years and 8 months · Proportion of participants
| Arm A (Ibrutinib, Rituximab) | 0.894 Proportion of participants |
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| Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 0.729 Proportion of participants |
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| p-value | <.001 |
| Hazard Ratio (HR) | 0.35 (95% CI 0.22–0.56) |
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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。