BENITIONSClinical Trial Intelligence

A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma

Phase 1/2 Completed NCT03323151

ConditionMantle-Cell Lymphoma
PhasePhase 1/2
SponsorPrECOG, LLC.
StatusCompleted
Enrollment43 participants
InterventionsIxazomib, Ixazomib, Ibrutinib, Ibrutinib
Start dateAug 13, 2018
Completion dateSep 22, 2022
Results postedJan 8, 2024

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
Phase I: Ixazomib & Ibrutinib (Dose Level 2)5 Participants
Phase I: Ixazomib & Ibrutinib (Dose Level 1)0 Participants
Phase I: Ixazomib & Ibrutinib (Dose Level 2)1 Participants
Phase I: Ixazomib & Ibrutinib (Dose Level 1)0 Participants
Phase I: Ixazomib & Ibrutinib (Dose Level 2)3 Participants

Phase II: Complete Response Rate

12 months · Participants

Phase II: Ixazomib & BTK Pre-Treated0 Participants
Phase II: Ixazomib & BTK-Naive11 Participants
Phase II: Ixazomib & BTK Pre-Treated2 Participants
Phase II: Ixazomib & BTK-Naive10 Participants
Phase II: Ixazomib & BTK Pre-Treated1 Participants
Phase II: Ixazomib & BTK-Naive0 Participants

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