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Hope for lymphoma patients: new drug cocktail targets resistant cancer

NCT ID NCT05890352

Disease control Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding either tazemetostat or zanubrutinib to a standard two-drug therapy (tafasitamab and lenalidomide) can shrink tumors or delay cancer return in people with large B-cell lymphoma that came back or didn't respond to prior treatment. About 227 adults who are not eligible for a stem cell transplant will participate. The goal is to find better treatment options for this hard-to-treat cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 227 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement non-Hodgkin lymphoma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Grade 3B follicular lymphoma High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements High-grade B-cell lymphoma Recurrent diffuse large B-cell lymphoma Refractory diffuse large B-cell lymphoma Transformed non-Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    104 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aurora Bay Area Medical Group-Marinette

    RECRUITING

    Marinette, Wisconsin, 54143, United States

  • Aurora BayCare Medical Center

    RECRUITING

    Green Bay, Wisconsin, 54311, United States

  • Aurora Cancer Care-Grafton

    RECRUITING

    Grafton, Wisconsin, 53024, United States

  • Aurora Cancer Care-Kenosha South

    RECRUITING

    Kenosha, Wisconsin, 53142, United States

  • Aurora Cancer Care-Milwaukee

    RECRUITING

    Milwaukee, Wisconsin, 53209, United States

  • Aurora Cancer Care-Milwaukee West

    RECRUITING

    Wauwatosa, Wisconsin, 53226, United States

  • Aurora Cancer Care-Racine

    RECRUITING

    Racine, Wisconsin, 53406, United States

  • Aurora Cancer Care-Southern Lakes VLCC

    RECRUITING

    Burlington, Wisconsin, 53105, United States

  • Aurora Health Care Germantown Health Center

    RECRUITING

    Germantown, Wisconsin, 53022, United States

  • Aurora Medical Center in Summit

    RECRUITING

    Summit, Wisconsin, 53066, United States

  • Aurora Saint Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Sinai Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53233, United States

  • Aurora West Allis Medical Center

    RECRUITING

    West Allis, Wisconsin, 53227, United States

  • Banner University Medical Center - Tucson

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Ben Taub General Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Cancer Hematology Centers - Flint

    RECRUITING

    Flint, Michigan, 48503, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • City of Hope Antelope Valley

    RECRUITING

    Lancaster, California, 93534, United States

    Contact Email: •••••@•••••

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • City of Hope Newport Beach

    RECRUITING

    Newport Beach, California, 92660, United States

  • City of Hope Seacliff

    RECRUITING

    Huntington Beach, California, 92648, United States

  • City of Hope South Bay

    RECRUITING

    Torrance, California, 90503, United States

  • City of Hope South Pasadena

    RECRUITING

    South Pasadena, California, 91030, United States

    Contact Email: •••••@•••••

  • City of Hope Upland

    RECRUITING

    Upland, California, 91786, United States

    Contact Email: •••••@•••••

  • City of Hope at Long Beach Elm

    RECRUITING

    Long Beach, California, 90813, United States

  • Duluth Clinic Ashland

    RECRUITING

    Ashland, Wisconsin, 54806, United States

    Contact Email: •••••@•••••

  • Essentia Health - Deer River Clinic

    RECRUITING

    Deer River, Minnesota, 56636, United States

    Contact Email: •••••@•••••

  • Essentia Health Cancer Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Essentia Health Hibbing Clinic

    RECRUITING

    Hibbing, Minnesota, 55746, United States

  • Essentia Health Sandstone

    RECRUITING

    Sandstone, Minnesota, 55072, United States

    Contact Email: •••••@•••••

  • Essentia Health Virginia Clinic

    RECRUITING

    Virginia, Minnesota, 55792, United States

    Contact Email: •••••@•••••

  • Genesee Hematology Oncology PC

    SUSPENDED

    Flint, Michigan, 48503, United States

  • Genesys Hurley Cancer Institute

    RECRUITING

    Flint, Michigan, 48503, United States

  • Gundersen Lutheran Medical Center

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

    Contact Email: •••••@•••••

  • Holy Cross Hospital

    RECRUITING

    Fort Lauderdale, Florida, 33308, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Hurley Medical Center

    RECRUITING

    Flint, Michigan, 48503, United States

  • Huron Gastroenterology PC

    RECRUITING

    Ypsilanti, Michigan, 48106, United States

  • Marshfield Medical Center - Minocqua

    RECRUITING

    Minocqua, Wisconsin, 54548, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Weston

    RECRUITING

    Weston, Wisconsin, 54476, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-EC Cancer Center

    RECRUITING

    Eau Claire, Wisconsin, 54701, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Rice Lake

    RECRUITING

    Rice Lake, Wisconsin, 54868, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-River Region at Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54482, United States

    Contact Email: •••••@•••••

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital East

    RECRUITING

    Shiloh, Illinois, 62269, United States

  • Mercy Hospital

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Mercy Medical Center - Des Moines

    RECRUITING

    Des Moines, Iowa, 50314, United States

    Contact Email: •••••@•••••

  • Mount Sinai Medical Center

    SUSPENDED

    Miami Beach, Florida, 33140, United States

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

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Northwest Cancer Center - Hobart

    RECRUITING

    Hobart, Indiana, 46342, United States

  • Northwest Cancer Center - Main Campus

    RECRUITING

    Crown Point, Indiana, 46307, United States

  • Northwest Cancer Center - Valparaiso

    RECRUITING

    Valparaiso, Indiana, 46383, United States

    Contact Email: •••••@•••••

  • Northwest Oncology LLC

    RECRUITING

    Dyer, Indiana, 46311, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Providence Newberg Medical Center

    RECRUITING

    Newberg, Oregon, 97132, United States

    Contact Email: •••••@•••••

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Providence Willamette Falls Medical Center

    RECRUITING

    Oregon City, Oregon, 97045, United States

    Contact Email: •••••@•••••

  • Saint Catherine Hospital

    RECRUITING

    Indianapolis, Indiana, 46312, United States

  • Saint Mary Medical Center

    RECRUITING

    Hobart, Indiana, 46342, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • The Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • ThedaCare Regional Cancer Center

    RECRUITING

    Appleton, Wisconsin, 54911, United States

    Contact Email: •••••@•••••

  • Tower Cancer Research Foundation

    RECRUITING

    Beverly Hills, California, 90211, United States

    Contact Email: •••••@•••••

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Trinity Health Medical Center - Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health Medical Center - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    RECRUITING

    Ann Arbor, Michigan, 48106, United States

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    RECRUITING

    Pontiac, Michigan, 48341, United States

  • Trinity Health Saint Mary Mercy Livonia Hospital

    RECRUITING

    Livonia, Michigan, 48154, United States

  • UC Comprehensive Cancer Center at Silver Cross

    RECRUITING

    New Lenox, Illinois, 60451, United States

    Contact Email: •••••@•••••

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    SUSPENDED

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    SUSPENDED

    Des Moines, Iowa, 50314, United States

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

    SUSPENDED

    Clive, Iowa, 50325, United States

  • University of Arizona Cancer Center-North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Chicago Medicine-Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

    Contact Email: •••••@•••••

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Michigan Health - Sparrow Lansing

    RECRUITING

    Lansing, Michigan, 48912, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • VCU Massey Cancer Center at Stony Point

    RECRUITING

    Richmond, Virginia, 23235, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Vince Lombardi Cancer Clinic - Oshkosh

    RECRUITING

    Oshkosh, Wisconsin, 54904, United States

  • Vince Lombardi Cancer Clinic-Sheboygan

    RECRUITING

    Sheboygan, Wisconsin, 53081, United States

  • Vince Lombardi Cancer Clinic-Two Rivers

    RECRUITING

    Two Rivers, Wisconsin, 54241, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Wilmot Cancer Institute at Webster

    RECRUITING

    Webster, New York, 14580, United States

    Contact Email: •••••@•••••

  • Women's Diagnostic Center - Munster

    RECRUITING

    Munster, Indiana, 46321, United States

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Other studies related to the condition(s) this trial covers.