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.

Conditions

• Adult Burkitt Lymphoma
• B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma
• Diffuse Large B-Cell Lymphoma
• MYC Gene Mutation
• Plasmablastic Lymphoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or intraventricularly

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Ixazomib Citrate

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Methotrexate

Given IT or intraventricularly

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Therapeutic Hydrocortisone

Given IT or intraventricularly

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Millennium Pharmaceuticals, Inc.

  collaborator INDUSTRY

• Northwestern University

  lead OTHER

Principal Investigators

• Barbara Pro, MD · Northwestern University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-28

Primary Completion

2020-09-26

Completion

2024-07-31

Countries

• United States

Study Locations