A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
1/2期
已完成
NCT03323151
| 适应症 | Mantle-Cell Lymphoma |
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| 分期 | 1/2期 |
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| 申办方 | PrECOG, LLC. |
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| 状态 | 已完成 |
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| 受试者人数 | 43 人 |
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| 干预(药物) | Ixazomib, Ixazomib, Ibrutinib, Ibrutinib |
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| 开始日期 | 2018年8月13日 |
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| 完成日期 | 2022年9月22日 |
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| 结果公布日 | 2024年1月8日 |
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摘要
Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib. Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy. Ixazomib is in a class of medications called proteasome inhibitors. Cancer cells depend on proteasome to provide this protein metabolism (turnover) function to regulate their growth and survival. Ixazomib disrupts a cancer cells' ability to survive by blocking the proteasome and disrupting protein metabolism. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether the addition of ixazomib to ibrutinib chemotherapy is effective in treating people who have relapsed or refractory MCL and to examine the side effects associated with ixazomib in combination with ibrutinib.
Phase I: Dose Limiting Toxicities (DLT) Rate
1 month · Participants
| Phase I: Ixazomib & Ibrutinib (Dose Level 1) | 3 Participants |
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| Phase I: Ixazomib & Ibrutinib (Dose Level 2) | 5 Participants |
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| Phase I: Ixazomib & Ibrutinib (Dose Level 1) | 0 Participants |
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| Phase I: Ixazomib & Ibrutinib (Dose Level 2) | 1 Participants |
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| Phase I: Ixazomib & Ibrutinib (Dose Level 1) | 0 Participants |
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| Phase I: Ixazomib & Ibrutinib (Dose Level 2) | 3 Participants |
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Phase II: Complete Response Rate
12 months · Participants
| Phase II: Ixazomib & BTK Pre-Treated | 0 Participants |
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| Phase II: Ixazomib & BTK-Naive | 11 Participants |
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| Phase II: Ixazomib & BTK Pre-Treated | 2 Participants |
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| Phase II: Ixazomib & BTK-Naive | 10 Participants |
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| Phase II: Ixazomib & BTK Pre-Treated | 1 Participants |
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| Phase II: Ixazomib & BTK-Naive | 0 Participants |
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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。