Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
3상
진행 중(모집 완료)
NCT02048813
| 대상 질환 | Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma |
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| 임상 단계 | 3상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 529 명 |
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| 중재(약물) | Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study |
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| 시작일 | 2014년 3월 10일 |
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| 완료일 | 2018년 10월 24일 |
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| 결과 공개일 | 2023년 8월 14일 |
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요약
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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