Adds targeted drugs to tafasitamab and lenalidomide for relapsed large B-cell lymphoma
Tests added targeted drugs with tafasitamab and lenalidomide in adults with returned large B-cell lymphoma.
Key facts
- Who runs it
- SWOG Cancer Research Network
- Where
- Ankeny, Ann Arbor, Appleton, Ashland, Beverly Hills, Brighton, Burlington, Canton, Cedar Rapids, Charleston, Chelsea, Chicago, City of Saint Peters, Clive, Creve Coeur, Crown Point, Danville, Deer River, Des Moines, Duarte, Duluth, Dyer, Eau Claire, Effingham, Flint, Fort Lauderdale, Germantown, Grafton, Green Bay, Hibbing, Hobart, Houston, Huntington Beach, Indianapolis, Jackson, Kenosha, La Crosse, Lancaster, Lansing, Livonia, Long Beach, Los Angeles, Marinette, Marshfield, Mattoon, Miami Beach, Milwaukee, Minocqua, Munster, New Lenox, New York, Newberg, Newport Beach, Oklahoma City, Oregon City, Orland Park, Oshkosh, Pontiac, Portland, Racine, Rice Lake, Richmond, Rochester, Salt Lake City, San Antonio, Sandstone, Sheboygan, Shiloh, South Pasadena, St Louis, Stevens Point, Summit, Torrance, Tucson, Two Rivers, Upland, Urbana, Valparaiso, Virginia, Wauwatosa, Webster, West Allis, Weston, and Ypsilanti, United StatesSee the 104 sites
- Trial code
- Registry title
- Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 227 people, planned
- Started
- 26 Sept 2023
- Expected to end
- Dec 2029
- Type of study
- Interventional, 5 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Biospecimen Collection
- Computed Tomography
- Lenalidomide
- Magnetic Resonance Imaging
- Positron Emission Tomography
- Quality-of-Life Assessment
- Questionnaire Administration
- Tafasitamab
- Tazemetostat
- Zanubrutinib
- Record updated
- 28 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with large B-cell lymphoma that came back or did not respond to earlier treatment, and who cannot or will not have a stem cell transplant.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Large B-cell lymphoma that returned or did not respond to treatment, including grade 3B follicular lymphoma, transformed lymphoma, and high grade B-cell lymphoma. Participants must have measurable disease on scans within 28 days before registration.
- Earlier treatment
- 1-5 earlier systemic treatments, including one multi-drug treatment for aggressive lymphoma. Earlier treatment must be finished and the person recovered from it. Earlier tafasitamab, lenalidomide, a BTK inhibitor or tazemetostat is not allowed.
- Biomarker or test result
- The lymphoma must be of germinal center type, as shown on the pathology report (Hans immunohistochemistry: CD10, BCL6, MUM1).
Main reasons for not taking part
- Lymphoma active in the central nervous system
- The investigator thinks the person is a candidate for autologous stem cell transplant and the person has not declined it
- Known allergy to tafasitamab, lenalidomide, tazemetostat or zanubrutinib
- Pregnant or nursing
- Taking certain medicines that affect CYP3A or direct vitamin K inhibitors
The registry criteria, word for word
Show all 33 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 have received prior treatment with tafasitamab and/or lenalidomide
- Participants must not have had prior BTK inhibitor or tazemetostat
- 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
- 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 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 any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib
- 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
Where in United States
- UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesContact: Katarina GasicNo longer taking part
- Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- ThedaCare Regional Cancer CenterAppleton, United StatesContact: Yazhini Vallatharasu (principal investigator)Taking people
- Duluth Clinic AshlandAshland, United StatesContact: Bret E. Friday (principal investigator)Taking people
- Tower Cancer Research FoundationBeverly Hills, United StatesContact: Akil A. Merchant (principal investigator)Taking people
- Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Trinity Health Medical Center - BrightonBrighton, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Aurora Cancer Care-Southern Lakes VLCCBurlington, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Trinity Health Medical Center - CantonCanton, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Mercy HospitalCedar Rapids, United StatesContact: Deborah W. Wilbur (principal investigator)Taking people
- Oncology Associates at Mercy Medical CenterCedar Rapids, United StatesContact: Deborah W. Wilbur (principal investigator)Taking people
- Medical University of South CarolinaCharleston, United StatesContact: Brian T. Hess (principal investigator)Taking people
- Chelsea HospitalChelsea, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- University of Chicago Comprehensive Cancer CenterChicago, United StatesContact: Justin P. Kline (principal investigator)Taking people
- University of IllinoisChicago, United StatesContact: Paul G. Rubinstein (principal investigator)Taking people
- Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesContact: Nancy L. Bartlett (principal investigator)Taking people
- UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesContact: Katarina GasicNo longer taking part
- Siteman Cancer Center at West County HospitalCreve Coeur, United StatesContact: Nancy L. Bartlett (principal investigator)Taking people
- Northwest Cancer Center - Main CampusCrown Point, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Carle at The RiverfrontDanville, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Essentia Health - Deer River ClinicDeer River, United StatesContact: Bret E. Friday (principal investigator)Taking people
- Mercy Medical Center - Des MoinesDes Moines, United StatesContact: Richard L. Deming (principal investigator)Taking people
- UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesContact: Katarina GasicNo longer taking part
- City of Hope Comprehensive Cancer CenterDuarte, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- Essentia Health Cancer CenterDuluth, United StatesContact: Bret E. Friday (principal investigator)Taking people
- Northwest Oncology LLCDyer, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesContact: Dean A. Delmastro (principal investigator)Taking people
- Carle Physician Group-EffinghamEffingham, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Cancer Hematology Centers - FlintFlint, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Genesys Hurley Cancer InstituteFlint, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Hurley Medical CenterFlint, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Genesee Hematology Oncology PCFlint, United StatesContact: Katarina GasicNo longer taking part
- Holy Cross HospitalFort Lauderdale, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Aurora Health Care Germantown Health CenterGermantown, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Aurora Cancer Care-GraftonGrafton, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Aurora BayCare Medical CenterGreen Bay, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Essentia Health Hibbing ClinicHibbing, United StatesContact: Bret E. Friday (principal investigator)Taking people
- Northwest Cancer Center - HobartHobart, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Saint Mary Medical CenterHobart, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesContact: Akiva Diamond (principal investigator)Taking people
- Ben Taub General HospitalHouston, United StatesContact: Akiva Diamond (principal investigator)Taking people
- City of Hope SeacliffHuntington Beach, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- Saint Catherine HospitalIndianapolis, United StatesContact: Suparna Mantha (principal investigator)Taking people
- University of Mississippi Medical CenterJackson, United StatesContact: Carrie K. Wynn (principal investigator)Taking people
- Aurora Cancer Care-Kenosha SouthKenosha, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Gundersen Lutheran Medical CenterLa Crosse, United StatesContact: David E. Marinier (principal investigator)Taking people
- City of Hope Antelope ValleyLancaster, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- University of Michigan Health - Sparrow LansingLansing, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- City of Hope at Long Beach ElmLong Beach, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Akil A. Merchant (principal investigator)Taking people
- Aurora Bay Area Medical Group-MarinetteMarinette, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Marshfield Medical Center-MarshfieldMarshfield, United StatesContact: Dean A. Delmastro (principal investigator)Taking people
- Carle Physician Group-Mattoon/CharlestonMattoon, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Mount Sinai Medical CenterMiami Beach, United StatesContact: Katarina GasicNo longer taking part
- Aurora Cancer Care-MilwaukeeMilwaukee, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Aurora Saint Luke's Medical CenterMilwaukee, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Aurora Sinai Medical CenterMilwaukee, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Marshfield Medical Center - MinocquaMinocqua, United StatesContact: Dean A. Delmastro (principal investigator)Taking people
- The Community HospitalMunster, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Women's Diagnostic Center - MunsterMunster, United StatesContact: Suparna Mantha (principal investigator)Taking people
- UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesContact: Justin P. Kline (principal investigator)Taking people
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesContact: Jennifer E. Amengual (principal investigator)Taking people
- Providence Newberg Medical CenterNewberg, United StatesContact: Charles W. Drescher (principal investigator)Taking people
- City of Hope Newport BeachNewport Beach, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: Taha Al-Juhaishi (principal investigator)Taking people
- Providence Willamette Falls Medical CenterOregon City, United StatesContact: Charles W. Drescher (principal investigator)Taking people
- University of Chicago Medicine-Orland ParkOrland Park, United StatesContact: Justin P. Kline (principal investigator)Taking people
- Vince Lombardi Cancer Clinic - OshkoshOshkosh, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Providence Portland Medical CenterPortland, United StatesContact: Charles W. Drescher (principal investigator)Taking people
- Providence Saint Vincent Medical CenterPortland, United StatesContact: Charles W. Drescher (principal investigator)Taking people
- Aurora Cancer Care-RacineRacine, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Marshfield Medical Center-Rice LakeRice Lake, United StatesContact: Dean A. Delmastro (principal investigator)Taking people
- VCU Massey Cancer Center at Stony PointRichmond, United StatesContact: Victor Y. Yazbeck (principal investigator)Taking people
- VCU Massey Comprehensive Cancer CenterRichmond, United StatesContact: Victor Y. Yazbeck (principal investigator)Taking people
- University of RochesterRochester, United StatesContact: Patrick M. Reagan (principal investigator)Taking people
- Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesContact: Allison Bock (principal investigator)Taking people
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesContact: Adolfo E. Diaz Duque (principal investigator)Taking people
- Essentia Health SandstoneSandstone, United StatesContact: Bret E. Friday (principal investigator)Taking people
- Vince Lombardi Cancer Clinic-SheboyganSheboygan, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Memorial Hospital EastShiloh, United StatesContact: Nancy L. Bartlett (principal investigator)Taking people
- City of Hope South PasadenaSouth Pasadena, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- Siteman Cancer Center at Christian HospitalSt Louis, United StatesContact: Nancy L. Bartlett (principal investigator)Taking people
- Siteman Cancer Center-South CountySt Louis, United StatesContact: Nancy L. Bartlett (principal investigator)Taking people
- Washington University School of MedicineSt Louis, United StatesContact: Nancy L. Bartlett (principal investigator)Taking people
- Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesContact: Dean A. Delmastro (principal investigator)Taking people
- Aurora Medical Center in SummitSummit, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- City of Hope South BayTorrance, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- Banner University Medical Center - TucsonTucson, United StatesContact: Krishna Rekha Moturi (principal investigator)Taking people
- University of Arizona Cancer Center-North CampusTucson, United StatesContact: Krishna Rekha Moturi (principal investigator)Taking people
- Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- City of Hope UplandUpland, United StatesContact: Alexey V. Danilov (principal investigator)Taking people
- Carle Cancer CenterUrbana, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Northwest Cancer Center - ValparaisoValparaiso, United StatesContact: Suparna Mantha (principal investigator)Taking people
- Essentia Health Virginia ClinicVirginia, United StatesContact: Bret E. Friday (principal investigator)Taking people
- Aurora Cancer Care-Milwaukee WestWauwatosa, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Wilmot Cancer Institute at WebsterWebster, United StatesContact: Patrick M. Reagan (principal investigator)Taking people
- Aurora West Allis Medical CenterWest Allis, United StatesContact: Thomas J. Saphner (principal investigator)Taking people
- Marshfield Medical Center - WestonWeston, United StatesContact: Dean A. Delmastro (principal investigator)Taking people
- Huron Gastroenterology PCYpsilanti, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesContact: Tareq Al baghdadi (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- Part I, Arm I (tafasitamab, lenalidomide, tazemetostat)Treatment being tested
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.
Treatment: Biospecimen Collection, Computed Tomography, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Tafasitamab, and Tazemetostat
- Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib)Treatment being tested
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.
Treatment: Biospecimen Collection, Computed Tomography, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Tafasitamab, and Zanubrutinib
- Part II, Arm I (tafasitamab, lenalidomide, tazemetostat)Treatment being tested
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.
Treatment: Biospecimen Collection, Computed Tomography, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Tafasitamab, and Tazemetostat
- Part II, Arm II (tafasitamab, lenalidomide)Existing treatment, for comparison
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.
Treatment: Biospecimen Collection, Computed Tomography, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, and Tafasitamab
- Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib)Treatment being tested
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.
Treatment: Biospecimen Collection, Computed Tomography, Lenalidomide, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration, Tafasitamab, and Zanubrutinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Adds targeted drugs to tafasitamab and lenalidomide for relapsed large B-cell lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 October 2026