Grade 3b Follicular LymphomaPhase 2NCT05890352
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Lenalidomide in people with Grade 3b Follicular Lymphoma and High Grade B-Cell Lymphoma, run by SWOG Cancer Research Network at 104 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 3b Follicular Lymphoma, High Grade B-Cell Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- What is being tested?
- Biospecimen Collection, Computed Tomography and Lenalidomide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 104 sitesUnited States
- Study dates
- 26 Sep 2023to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have:
- Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines
- Follicular lymphoma, grade 3B
- Transformed lymphoma
- High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements
- Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter >= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 28 days prior to registration. All disease must be documented on the Baseline Tumor Assessment Form.
Show all 32Show fewer
- Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report.
- Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma
- Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy
- Steroid use for the control of non-Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to Cycle 1, Day 1
- Participant must be >= 18 years old
- Participant must have Zubrod Performance Status of 0-3
- Participant must have a complete medical history and physical exam within 28 days prior to registration
- Absolute neutrophil count >= 1.0 x 10^3/uL (within 28 days prior to registration)
- If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Absolute neutrophil count (ANC) >= 0.75 x 10^3/uL
- Platelets >= 75 x 10^3/uL (within 28 days prior to registration)
- If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Platelets >= 50 x 10^3/uL
- Aspartate aminotransferase (AST) =< 3 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =< 3 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.
- Participants with lymphomatous involvement of the liver must have AST =< 5 x IULN, ALT =< 5 x IULN
- Total bilirubin =< 1.5 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.
- Participants with lymphomatous involvement of the liver must have total bilirubin =< 5 x IULN
- Participants must have a calculated creatinine clearance >= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- Participants must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy
- Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to registration
- Participants must be able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
- Participants who can complete the FACT-Lym and PRO-CTCAE forms in English or Spanish must agree to participate in the patient-reported outcome study
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations.
Who cannot join
- Participants must not have active lymphomatous involvement of the central nervous system (CNS) because the treatments used in this study are not effective to sufficiently penetrate the blood brain barrier
- Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing. Testing is not required for eligibility determination
- Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute leukemia (T-ALL). Testing is not required for eligibility determination
- Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or cellular therapy (such as chimeric antigen receptor (CAR) T-cell) are eligible
- Participants must not have received prior treatment with tafasitamab and/or lenalidomide
- Participants must not have had prior BTK inhibitor or tazemetostat
Show all 11Show fewer
- Participants must not have any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib
- Participants must not be receiving direct vitamin K inhibitors or strong or moderate CYP3A inhibitors or inducers at the date of registration
- Notes: Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not be pregnant or nursing and must follow the guidelines according to the lenalidomide Risk Evaluation and Mitigation Strategies (REMS) program. The effects of tazemetostat, zanubrutinib, lenalidomide and tafasitamab, and the combination of these drugs have not been studied on the developing human fetus are the effects are unknown. Individuals who are of reproductive potential must have agreed to use a highly effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential". In addition to routine contraceptive methods, "acceptable contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
Trial locations and contacts
104 sites in 1 country. Contact the study team or a site near you to ask about taking part.
104 sites in 1 country
United States104 sites, 99 recruiting
- Suspended
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Yazhini Vallatharasu
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Akil A. Merchant
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Brian T. Hess
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Paul G. Rubinstein
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Justin P. Kline
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Suspended
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307
Site Public Contact, 219-310-2550
Suparna Mantha
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-358-6613, cancerresearch@mercydesmoines.org
Richard L. Deming
- Suspended
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Alexey V. Danilov
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwest Oncology LLC
Dyer, Indiana, 46311
Site Public Contact, 219-924-8178
Suparna Mantha
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghdadi
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghdadi
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Tareq Al baghdadi
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Tareq Al baghdadi
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Site Public Contact, 219-947-1795
Suparna Mantha
- Recruiting
Saint Mary Medical Center
Hobart, Indiana, 46342
Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
Suparna Mantha
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Akiva Diamond
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Site Public Contact, 713-873-2000
Akiva Diamond
- Recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Site Public Contact, 626-256-4673
Alexey V. Danilov
- Recruiting
Saint Catherine Hospital
Indianapolis, Indiana, 46312
Site Public Contact, protocols@swog.org
Suparna Mantha
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
Carrie K. Wynn
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Alexey V. Danilov
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Tareq Al baghdadi
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
City of Hope at Long Beach Elm
Long Beach, California, 90813
Site Public Contact, 877-467-3411
Alexey V. Danilov
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-8965
Akil A. Merchant
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Suspended
Mount Sinai Medical Center
Miami Beach, Florida, 33140
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
The Community Hospital
Munster, Indiana, 46321
Site Public Contact, 219-836-3349
Suparna Mantha
- Recruiting
Women's Diagnostic Center - Munster
Munster, Indiana, 46321
Site Public Contact, 219-934-8869, mnicholson@comhs.org
Suparna Mantha
- Recruiting
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Justin P. Kline
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Jennifer E. Amengual
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
City of Hope Newport Beach
Newport Beach, California, 92660
Site Public Contact, 877-467-3411
Alexey V. Danilov
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Taha Al-Juhaishi
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Justin P. Kline
- Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Victor Y. Yazbeck
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Victor Y. Yazbeck
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Patrick M. Reagan
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Allison Bock
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu
Adolfo E. Diaz Duque
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Nancy L. Bartlett
- Recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Alexey V. Danilov
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Nancy L. Bartlett
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
City of Hope South Bay
Torrance, California, 90503
Site Public Contact, 877-467-3411
Alexey V. Danilov
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Krishna Rekha Moturi
- Recruiting
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Site Public Contact, UACC-IIT@uacc.arizona.edu
Krishna Rekha Moturi
- Recruiting
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
City of Hope Upland
Upland, California, 91786
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Alexey V. Danilov
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383
Site Public Contact, 219-836-6875, CancerResearch@COMHS.org
Suparna Mantha
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Wilmot Cancer Institute at Webster
Webster, New York, 14580
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Patrick M. Reagan
- Recruiting
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Dean A. Delmastro
- Recruiting
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Tareq Al baghdadi
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the recommended phase II dose of tafasitamab + lenalidomide + tazemetostat AND of tafasitamab + lenalidomide + zanubrutinib. (Safety Run-in) II. To compare progression-free survival (PFS) of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) treated with tafasitamab + lenalidomide + tazemetostat vs control (tafasitamab + lenalidomide) AND treated with tafasitamab + lenalidomide + zanubrutinib versus (vs) control. (Randomized Phase II Study)
SECONDARY OBJECTIVES:
- To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalidomide + tazemetostat in germinal center B-cell (GCB) and non-GCB (activated B-cell [ABC]/unclassified) subsets.
II. To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalidomide + zanubrutinib in GCB and non-GCB (ABC/unclassified) subsets.
III. To estimate progression-free survival (PFS), overall response rate (ORR), complete response rate (CR), partial response rate (PR), duration of response (DOR), event-free survival (EFS), overall survival (OS), in GCB and non-GCB LBCL for each treatment.
IV. To evaluate adverse events within each treatment arm.
OTHER OBJECTIVES:
- To explore PFS within subgroups defined by molecular profile (e.g., MCD, BN2, N1 and EZB) and genetic subtypes.
II. To explore PFS in the tafasitamab-lenalidomide control arm vs that in matched historical control from L-MIND and realMIND studies.
III. To assess frailty (Cumulative Illness Rating Scale [CIRS] and Timed Get Up and Go [TUG]) and its correlation with outcome.
PRIMARY PATIENT-REPORTED OUTCOMES OBJECTIVE:
- To compare patient-reported lymphoma-specific symptoms as measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index sub-scale at 3 months after randomization between the control arm and each experimental arm (Arm 1 versus Arm 2 and Arm 3 versus Arm 2).
SECONDARY PATIENT-REPORTED OUTCOMES OBJECTIVE:
- To compare participant-reported toxicity (treatment side effect) symptoms using selected Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items between experimental vs control arms.
EXPLORATORY PATIENT-REPORTED OUTCOMES OBJECTIVES:
- To compare patient-reported quality of life using the FACT-General (G) subscale score and the FACT-Lym total score at 3 months after randomization between the control arm and each experimental arm.
II. To compare quality of life over time between treatment arms from baseline to 12 months after randomization as measured by the FACT-Lym trial outcome index (TOI), FACT-G, and FACT-Lym total score using longitudinal analysis.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: This is a dose-escalation study of tazemetostat and zanubrutinib.
PART I (SAFETY RUN-IN): Patients are assigned to 1 of 2 arms per treating investigator's choice.
ARM I: Patients receive tafasitamab intravenously (IV), lenalidomide orally (PO), and tazemetostat PO on study. Patients also undergo positron emission tomography/computed tomography (PET/CT) and CT or magnetic resonance imaging (MRI) scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM III: Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
PART II: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM II: Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM III: Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
- 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
- Being tested
- Biospecimen Collection, Computed Tomography, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo optional collection of blood
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT and CT
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
TafasitamabBiological
Also called Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR-00208, MOR00208
Given IV
TazemetostatDrug
Also called E7438, EPZ-6438, EPZ6438
Given PO
ZanubrutinibDrug
Also called BGB-3111, Brukinsa, BTK-InhB
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Part I, Arm I (tafasitamab, lenalidomide, tazemetostat) | Experimental | Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Biological: Tafasitamab; Drug: Tazemetostat |
| Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib) | Experimental | Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Tafasitamab; Drug: Zanubrutinib |
| Part II, Arm I (tafasitamab, lenalidomide, tazemetostat) | Experimental | Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Tafasitamab; Drug: Tazemetostat |
| Part II, Arm II (tafasitamab, lenalidomide) | Active comparator | Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Tafasitamab |
| Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) | Experimental | Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Tafasitamab; Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Will be compared between participants randomized to control Arm 2 (tafasitamab + lenalidomide) versus (vs) experimental Arm 1 (tafasitamab + lenalidomide + tazemetostat), AND control Arm 2 vs experimental Arm 3 (tafasitamab + lenalidomide + zanubrutinib), respectively.
Measured: From date of randomization to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 3 years
Trial Outcome Index (TOI) score from the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) (Patient Reported Outcome [PRO] Study)
Will compare the trial outcome index (TOI) score between each experimental arm (Arm 1 and Arm 3) to the control arm (Arm 2). The TOI score is composed of the Physical Well-Being, Functional Well-Being, and lymphoma-specific subscale scores. The scores range from 0-116, with higher scores indicating a higher quality of life.
Measured: Baseline up to 3 months after randomization
Secondary outcomes (10)
Hazard ratio for PFS in the germinal center B-cell (GCB) subgroup
Will calculate the 80% confidence interval (CI) for the Cox regression time-to-event estimate of the hazard ratio associated with addition of tazemetostat to tafasitamab+lenalidomide combination (Arm 2 vs Arm 1) in the GCB subgroup. If the confidence interval excludes 1, then 80% CI will be calculated for the non-GCB group.
Measured: Up to 3 years
Hazard ratio for PFS in the non-GCB subgroup
Will calculate the 80% CI for the hazard ratio associated with addition of zanubrutinib to tafasitamab+lenalidomide combination (Arm 2 vs Arm 3) in the non-GCB subgroup. If the confidence interval excludes 1, then 80% CI will be calculated for the GCB group.
Measured: Up to 3 years
PFS
Will estimate in GCB and non-GCB large B-cell lymphoma (LBCL) for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: From date of randomization to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 3 years
Overall response rate (ORR)
Will estimate in GCB and non-GCB LBCL for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: Up to 3 years
Complete response (CR) rate
Will estimate in GCB and non-GCB LBCL for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: Up to 3 years
Partial response (PR) rate
Will estimate in GCB and non-GCB LBCL for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: Up to 3 years
Duration of response (DOR)
Will estimate in GCB and non-GCB LBCL for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: From date of first documentation of response to treatment (CR, PR) to date of first documentation of progression, or death due to any cause among patients who achieve a response (CR or PR), assessed up to 3 years
Event free survival (EFS)
Will estimate in GCB and non-GCB LBCL for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: From date of randomization to date of first occurrence of EFS event, assessed up to 3 years
Overall survival (OS)
Will estimate in GCB and non-GCB LBCL for each treatment. Will be estimated using the method of Kaplan-Meier and 80% confidence interval will be calculated.
Measured: From date of randomization to date of death due to any cause, assessed up to 3 years
Incidence of adverse events
Will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5. Eligible participants receiving at least one dose of drug will be included in the assessment of adverse events by treatment arms. The maximum Grade for each toxicity will be recorded for each participant, and frequency tables will be reviewed to determine toxicity patterns. With 60 eligible participants in each arm, any toxicity occurring with at least 5% probability is likely to be seen at least once (95% chance). Toxicity rates in each arm can be estimated to within at least +/- 13% with 95% confidence.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start26 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 3b Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), BeiGene, Ipsen, Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Jennifer E Amengual, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890352
- Sponsor's protocol ID
- S2207
- Other IDs
- NCI-2023-02518, S2207, S2207, U10CA180888
- Status last verified
- Oct 2025
- First submitted
- 25 May 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05890352
- Acronym / sponsor ID
- S2207
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), BeiGene, Ipsen, Incyte Corporation
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the recommended phase II dose of tafasitamab + lenalidomide + tazemetostat AND of tafasitamab + lenalidomide + zanubrutinib. (Safety Run-in) II. To compare progression-free survival (PFS) of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) treated with tafasitamab + lenalidomide + tazemetostat vs control (tafasitamab + lenalidomide) AND treated with tafasitamab + lenalidomide + zanubrutinib versus (vs) control. (Randomized Phase II Study)
SECONDARY OBJECTIVES:
- To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalidomide + tazemetostat in germinal center B-cell (GCB) and non-GCB (activated B-cell [ABC]/unclassified) subsets.
II. To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalidomide + zanubrutinib in GCB and non-GCB (ABC/unclassified) subsets.
III. To estimate progression-free survival (PFS), overall response rate (ORR), complete response rate (CR), partial response rate (PR), duration of response (DOR), event-free survival (EFS), overall survival (OS), in GCB and non-GCB LBCL for each treatment.
IV. To evaluate adverse events within each treatment arm.
OTHER OBJECTIVES:
- To explore PFS within subgroups defined by molecular profile (e.g., MCD, BN2, N1 and EZB) and genetic subtypes.
II. To explore PFS in the tafasitamab-lenalidomide control arm vs that in matched historical control from L-MIND and realMIND studies.
III. To assess frailty (Cumulative Illness Rating Scale [CIRS] and Timed Get Up and Go [TUG]) and its correlation with outcome.
PRIMARY PATIENT-REPORTED OUTCOMES OBJECTIVE:
- To compare patient-reported lymphoma-specific symptoms as measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index sub-scale at 3 months after randomization between the control arm and each experimental arm (Arm 1 versus Arm 2 and Arm 3 versus Arm 2).
SECONDARY PATIENT-REPORTED OUTCOMES OBJECTIVE:
- To compare participant-reported toxicity (treatment side effect) symptoms using selected Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items between experimental vs control arms.
EXPLORATORY PATIENT-REPORTED OUTCOMES OBJECTIVES:
- To compare patient-reported quality of life using the FACT-General (G) subscale score and the FACT-Lym total score at 3 months after randomization between the control arm and each experimental arm.
II. To compare quality of life over time between treatment arms from baseline to 12 months after randomization as measured by the FACT-Lym trial outcome index (TOI), FACT-G, and FACT-Lym total score using longitudinal analysis.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE: This is a dose-escalation study of tazemetostat and zanubrutinib.
PART I (SAFETY RUN-IN): Patients are assigned to 1 of 2 arms per treating investigator's choice.
ARM I: Patients receive tafasitamab intravenously (IV), lenalidomide orally (PO), and tazemetostat PO on study. Patients also undergo positron emission tomography/computed tomography (PET/CT) and CT or magnetic resonance imaging (MRI) scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM III: Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
PART II: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM II: Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM III: Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part I, Arm I (tafasitamab, lenalidomide, tazemetostat) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Lenalidomide, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Biological: Tafasitamab, Drug: TazemetostatPatients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. |
| Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Lenalidomide, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Biological: Tafasitamab, Drug: ZanubrutinibPatients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. |
| Part II, Arm I (tafasitamab, lenalidomide, tazemetostat) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Lenalidomide, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Biological: Tafasitamab, Drug: TazemetostatPatients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. |
| Part II, Arm II (tafasitamab, lenalidomide) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Lenalidomide, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Biological: TafasitamabPatients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. |
| Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Lenalidomide, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Biological: Tafasitamab, Drug: ZanubrutinibPatients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Participants must have:
- Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter >= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 28 days prior to registration. All disease must be documented on the Baseline Tumor Assessment Form.
- Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report.
- Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma
- Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy
Key exclusion criteria (11 listed)
- Participants must not have active lymphomatous involvement of the central nervous system (CNS) because the treatments used in this study are not effective to sufficiently penetrate the blood brain barrier
- Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing. Testing is not required for eligibility determination
- Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute leukemia (T-ALL). Testing is not required for eligibility determination
- Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or cellular therapy (such as chimeric antigen receptor (CAR) T-cell) are eligible
- Participants must not have received prior treatment with tafasitamab and/or lenalidomide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo optional collection of blood | Procedure or surgery | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT and CT | Procedure or surgery | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceUndergo MRI | Procedure or surgery | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| Questionnaire AdministrationAncillary studies | Other | Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| TafasitamabAlso: Immunoglobulin, Anti-(Human Cd19 Antigen) (Human-mus musculus Monoclonal MOR00208 Heavy Chain), Disulfide with Human-mus musculus Monoclonal MOR00208 .Kappa.-chain, Dimer, Monjuvi, MOR-00208, MOR00208Given IV | Biological | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm II (tafasitamab, lenalidomide), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
| TazemetostatAlso: E7438, EPZ-6438, EPZ6438Given PO | Drug | Part I, Arm I (tafasitamab, lenalidomide, tazemetostat), Part II, Arm I (tafasitamab, lenalidomide, tazemetostat) |
| ZanubrutinibAlso: BGB-3111, Brukinsa, BTK-InhBGiven PO | Drug | Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib), Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib) |
Primary outcome
Progression-free survival (PFS)
Time frame: From date of randomization to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 3 years
Will be compared between participants randomized to control Arm 2 (tafasitamab + lenalidomide) versus (vs) experimental Arm 1 (tafasitamab + lenalidomide + tazemetostat), AND control Arm 2 vs experimental Arm 3 (tafasitamab + lenalidomide + zanubrutinib), respectively.
Trial Outcome Index (TOI) score from the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) (Patient Reported Outcome [PRO] Study)
Time frame: Baseline up to 3 months after randomization
Will compare the trial outcome index (TOI) score between each experimental arm (Arm 1 and Arm 3) to the control arm (Arm 2). The TOI score is composed of the Physical Well-Being, Functional Well-Being, and lymphoma-specific subscale scores. The scores range from 0-116, with higher scores indicating a higher quality of life.
10 secondary outcomes
Hazard ratio for PFS in the germinal center B-cell (GCB) subgroup
Time frame: Up to 3 years
Hazard ratio for PFS in the non-GCB subgroup
Time frame: Up to 3 years
PFS
Time frame: From date of randomization to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 3 years
Overall response rate (ORR)
Time frame: Up to 3 years
Complete response (CR) rate
Time frame: Up to 3 years
Partial response (PR) rate
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: From date of first documentation of response to treatment (CR, PR) to date of first documentation of progression, or death due to any cause among patients who achieve a response (CR or PR), assessed up to 3 years
Event free survival (EFS)
Time frame: From date of randomization to date of first occurrence of EFS event, assessed up to 3 years
Overall survival (OS)
Time frame: From date of randomization to date of death due to any cause, assessed up to 3 years
Incidence of adverse events
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Related trials for Grade 3b Follicular Lymphoma
RecruitingPhase 2
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
Large B-Cell Lymphoma With IRF4 Rearrangement, Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma
RecruitingPhase 2
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
Active, not recruitingPhase 1
Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma
B Cell Lymphoma, Aggressive Lymphoma
RecruitingPhase 1
CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma
RecruitingPhase 1/2
A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
Lymphoma, B Cell, Lymphoma Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer E Amengual principal investigator
SWOG Cancer Research Network
104 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Lenalidomide in people with Grade 3b Follicular Lymphoma and High Grade B-Cell Lymphoma, run by SWOG Cancer Research Network at 104 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarina Gasic (210-677-8808, kgasic@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From date of randomization to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.