Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
第3相
実施中(募集終了)
NCT02048813
| 対象疾患 | Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma |
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| 相 | 第3相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 529 名 |
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| 介入(薬剤) | Cyclophosphamide, Fludarabine Phosphate, Ibrutinib, Laboratory Biomarker Analysis, Pharmacogenomic Study |
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| 開始日 | 2014年3月10日 |
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| 完了日 | 2018年10月24日 |
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| 結果公開日 | 2023年8月14日 |
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概要
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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