A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
Phase 1/2
Completed
NCT03323151
| Condition | Mantle-Cell Lymphoma |
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| Phase | Phase 1/2 |
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| Sponsor | PrECOG, LLC. |
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| Status | Completed |
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| Enrollment | 43 participants |
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| Interventions | Ixazomib, Ixazomib, Ibrutinib, Ibrutinib |
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| Start date | Aug 13, 2018 |
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| Completion date | Sep 22, 2022 |
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| Results posted | Jan 8, 2024 |
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Summary
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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Open in BENITIONS
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