Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment

Summary

This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.

Conditions

• Grade 3b Follicular Lymphoma
• High Grade B-Cell Lymphoma
• High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
• Recurrent Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Transformed Non-Hodgkin Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo optional collection of blood

PROCEDURE

Computed Tomography

Undergo PET/CT and CT

DRUG

Lenalidomide

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Tafasitamab

Given IV

DRUG

Tazemetostat

Given PO

DRUG

Zanubrutinib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• BeiGene

  collaborator INDUSTRY

• Ipsen

  collaborator INDUSTRY

• Incyte Corporation

  collaborator INDUSTRY

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Jennifer E Amengual · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-26

Primary Completion

2026-12-31

Completion

2029-01-31

FDA Drug

Yes

Countries

• United States

Study Locations