RecruitingPhase 2NCT05890352

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

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-Cell Lymphoma

Sponsor

SWOG Cancer Research Network

Enrollment

227 participants

Start Date

Sep 26, 2023

Study Type

INTERVENTIONAL

Conditions

Grade 3b Follicular Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests new drug combinations on top of standard treatment for people with large B-cell lymphoma (an aggressive blood cancer) that has come back or stopped responding to previous therapy. **You may be eligible if...** - You have been confirmed to have relapsed or treatment-resistant large B-cell lymphoma, grade 3B follicular lymphoma, transformed lymphoma, or related high-grade B-cell lymphomas - Your cancer has returned or did not respond to prior treatments **You may NOT be eligible if...** - Your lymphoma type does not match the specific subtypes included in the trial - You have not had prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo optional collection of blood

PROCEDUREComputed Tomography

Undergo PET/CT and CT

DRUGLenalidomide

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

BIOLOGICALTafasitamab

Given IV

DRUGTazemetostat

Given PO

DRUGZanubrutinib

Given PO

Locations(104)

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope Seacliff

Huntington Beach, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

City of Hope at Long Beach Elm

Long Beach, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

City of Hope Newport Beach

Newport Beach, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope South Bay

Torrance, California, United States

City of Hope Upland

Upland, California, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwest Cancer Center - Main Campus

Crown Point, Indiana, United States

Northwest Oncology LLC

Dyer, Indiana, United States

Northwest Cancer Center - Hobart

Hobart, Indiana, United States

Saint Mary Medical Center

Hobart, Indiana, United States

Saint Catherine Hospital

Indianapolis, Indiana, United States

The Community Hospital

Munster, Indiana, United States

Women's Diagnostic Center - Munster

Munster, Indiana, United States

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Wilmot Cancer Institute at Webster

Webster, New York, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

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NCT05890352