Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia
第3相
実施中(募集終了)
NCT03737981
| 対象疾患 | 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 | 465 名 |
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| 介入(薬剤) | Ibrutinib, Obinutuzumab, Observation Activity, Venetoclax |
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| 開始日 | 2019年1月31日 |
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| 完了日 | 2025年1月17日 |
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| 結果公開日 | 2026年2月2日 |
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概要
This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
Progression-free Survival (PFS)
5 years · proportion of participants w/out event
| Arm I (Ibrutinib, Obinutuzumab) | 0.59 proportion of participants w/out event |
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| Arm II (Ibrutinib, Obinutuzumab, Venetoclax) | 0.68 proportion of participants w/out event |
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| p-value | 0.2414 |
| Hazard Ratio (HR) | 0.89 (95% CI 0.64–1.24) |
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