Actively Recruiting
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
Led by SWOG Cancer Research Network ยท Updated on 2025-10-20
227
Participants Needed
104
Research Sites
274 weeks
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.
CONDITIONS
Official Title
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically confirmed relapsed or refractory large B-cell lymphoma or related types including grade 3B follicular lymphoma, transformed lymphoma, and high grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements
- Cell of origin determination of germinal center B-cell subtype based on pathology report
- 1 to 5 prior systemic treatment regimens including at least one multiagent regimen for aggressive lymphoma
- Completed prior systemic therapy and recovered from previous treatment effects
- Steroid use for lymphoma symptoms allowed but must be stopped before first treatment cycle
- Zubrod Performance Status of 0 to 3
- Complete medical history and physical exam within 28 days before registration
- Absolute neutrophil count of at least 1.0 x 10^3/uL (or 0.75 x 10^3/uL if bone marrow involved) within 28 days before registration
- Platelet count of at least 75 x 10^3/uL (or 50 x 10^3/uL if bone marrow involved) within 28 days before registration
- AST and ALT levels at or below 3 times the institutional upper limit of normal, or up to 5 times if liver involved
- Total bilirubin at or below 1.5 times institutional upper limit of normal, or up to 5 times if liver involved
- Calculated creatinine clearance of at least 30 mL/min within 28 days before registration
- Clinical cardiac risk assessment of class 2B or better if history of cardiac disease
- Recovered from adverse events of prior anti-cancer therapy except alopecia
- For HIV positive participants, on effective anti-retroviral therapy with undetectable viral load within 6 months
- For hepatitis B infection, undetectable viral load with suppressive therapy
- For hepatitis C infection, undetectable viral load within 28 days before registration
- Able to swallow and retain oral medication without significant gastrointestinal issues
- Agree to participate in specimen banking
- Able to complete FACT-Lym and PRO-CTCAE forms in English or Spanish
- Provide informed consent according to guidelines
You will not qualify if you...
- Active lymphoma involvement of the central nervous system
- Known abnormalities linked to myelodysplastic syndrome or myeloproliferative neoplasms
- History of T-cell lymphoblastic lymphoma or T-cell acute leukemia
- Candidate for or declined autologous stem cell transplant, except those with disease progression after stem cell transplant or cellular therapy
- Prior treatment with tafasitamab and/or lenalidomide
- Prior treatment with BTK inhibitors or tazemetostat
- Known allergy or reaction to study drugs (tafasitamab, lenalidomide, tazemetostat, zanubrutinib)
- Currently taking direct vitamin K inhibitors or strong/moderate CYP3A inhibitors or inducers
- Prior or concurrent malignancy that may interfere with safety or efficacy assessments
- Pregnant or nursing; must follow lenalidomide Risk Evaluation and Mitigation Strategies including use of effective contraception if of reproductive potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 104 locations
1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
3
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
Actively Recruiting
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
5
City of Hope Seacliff
Huntington Beach, California, United States, 92648
Actively Recruiting
6
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
7
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
8
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
9
City of Hope Newport Beach
Newport Beach, California, United States, 92660
Actively Recruiting
10
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
11
City of Hope South Bay
Torrance, California, United States, 90503
Actively Recruiting
12
City of Hope Upland
Upland, California, United States, 91786
Actively Recruiting
13
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
14
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Suspended
15
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
16
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
18
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
19
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
20
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
21
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
22
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
23
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
24
Northwest Cancer Center - Main Campus
Crown Point, Indiana, United States, 46307
Actively Recruiting
25
Northwest Oncology LLC
Dyer, Indiana, United States, 46311
Actively Recruiting
26
Northwest Cancer Center - Hobart
Hobart, Indiana, United States, 46342
Actively Recruiting
27
Saint Mary Medical Center
Hobart, Indiana, United States, 46342
Actively Recruiting
28
Saint Catherine Hospital
Indianapolis, Indiana, United States, 46312
Actively Recruiting
29
The Community Hospital
Munster, Indiana, United States, 46321
Actively Recruiting
30
Women's Diagnostic Center - Munster
Munster, Indiana, United States, 46321
Actively Recruiting
31
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States, 46383
Actively Recruiting
32
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Suspended
33
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
34
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
35
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Suspended
36
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
37
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Suspended
38
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States, 48106
Actively Recruiting
39
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
40
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States, 48114
Actively Recruiting
41
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
42
Trinity Health Medical Center - Canton
Canton, Michigan, United States, 48188
Actively Recruiting
43
Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
44
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States, 48118
Actively Recruiting
45
Cancer Hematology Centers - Flint
Flint, Michigan, United States, 48503
Actively Recruiting
46
Genesee Hematology Oncology PC
Flint, Michigan, United States, 48503
Suspended
47
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Actively Recruiting
48
Hurley Medical Center
Flint, Michigan, United States, 48503
Actively Recruiting
49
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States, 48912
Actively Recruiting
50
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States, 48154
Actively Recruiting
51
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
Actively Recruiting
52
Huron Gastroenterology PC
Ypsilanti, Michigan, United States, 48106
Actively Recruiting
53
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
54
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
55
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
56
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
57
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
58
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
59
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
60
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
61
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
62
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
63
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
64
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
65
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
66
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
67
Wilmot Cancer Institute at Webster
Webster, New York, United States, 14580
Actively Recruiting
68
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
69
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
70
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
71
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
72
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
73
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
74
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
75
Ben Taub General Hospital
Houston, Texas, United States, 77030
Actively Recruiting
76
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
77
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
78
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
79
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
80
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States, 54911
Actively Recruiting
81
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
82
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
Actively Recruiting
83
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
84
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Actively Recruiting
85
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Actively Recruiting
86
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Actively Recruiting
87
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Actively Recruiting
88
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
89
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States, 54143
Actively Recruiting
90
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
91
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Actively Recruiting
92
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
93
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Actively Recruiting
94
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
95
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Actively Recruiting
96
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Actively Recruiting
97
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
98
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
99
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
100
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Actively Recruiting
101
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Actively Recruiting
102
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Actively Recruiting
103
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Actively Recruiting
104
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
Research Team
K
Katarina Gasic
CONTACT
C
Crystal Miwa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here