A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
第1/2相
完了
NCT03323151
| 対象疾患 | Mantle-Cell Lymphoma |
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| 相 | 第1/2相 |
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| スポンサー | PrECOG, LLC. |
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| ステータス | 完了 |
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| 参加者数 | 43 名 |
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| 介入（薬剤） | Ixazomib, Ixazomib, Ibrutinib, Ibrutinib |
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| 開始日 | 2018年8月13日 |
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| 完了日 | 2022年9月22日 |
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| 結果公開日 | 2024年1月8日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
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