Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma

Summary

The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.

Timeline

Start

2015-10-28

Primary completion

2020-09-26

Completion

2024-07

Publications

• Karmali R, Galvez C, Hamadani M, Gordon L, Winter J, Ma S, Nelson V, Fenske TS, Shah NN, Jagadeesh D, Klein A, Helenowski I, Chen R, Mi X, Petrich A, Evens AM, Pro B. A phase 1-2 trial of DA-EPOCH-R plus ixazomib for MYC-aberrant lymphoid malignancies: the DACIPHOR regimen. Blood Adv. 2024 Apr 9;8(7):1612-1620. doi: 10.1182/bloodadvances.2023011369.

Drugs

Indications