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

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.

Timeline

Start

2018-08-13

Primary completion

2022-09-22

Completion

2023-09-07

Publications

• Results Cohen JB, Portell CA, Hamadani M, Jegede O, Diefenbach C, Fletcher C, Matasar M, Landsburg D, Mantha S, Kahl B. An Evaluation of Ibrutinib and Ixazomib in Patients With Relapsed/Refractory Mantle Cell Lymphoma: PrE0404. Clin Lymphoma Myeloma Leuk. 2026 Jul;26(7):465-473.e1. doi: 10.1016/j.clml.2026.04.025. Epub 2026 May 4.

Drugs

Indications