Actively Recruiting
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Led by SWOG Cancer Research Network ยท Updated on 2026-02-02
396
Participants Needed
87
Research Sites
367 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 II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.
CONDITIONS
Official Title
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis confirmed as diffuse large B-cell lymphoma, follicular lymphoma grade 3b, or primary mediastinal large B-cell lymphoma
- Patients with transformed diffuse large B-cell lymphoma from follicular or marginal zone lymphoma
- At least one measurable lesion larger than 1.5 cm
- Asymptomatic if secondary central nervous system lymphoma is present
- Registered prior to lymphodepleting chemotherapy for FDA-approved CAR T-cell therapy
- Planning to receive commercial CD19 CAR T-cell therapy
- Allowed to receive bridging therapy excluding polatuzumab vedotin and mosunetuzumab
- Planned PET-CT scan within 60 days before starting lymphodepleting chemotherapy
- Previously treated with polatuzumab vedotin or mosunetuzumab before leukapheresis if no refractory disease or relapse within 6 months
- CAR T-cell infusion planned between 2 and 14 days after lymphodepleting chemotherapy
- Lymphodepleting chemotherapy to start within 60 days of registration
- Age 18 years or older
- Zubrod performance status of 0, 1, or 2
- Total bilirubin less than or equal to 2 times the upper limit of normal unless due to Gilbert's disease or liver lymphoma
- AST and ALT levels less than or equal to 3 times the upper limit of normal
- Creatinine clearance of at least 40 mL/min
- Cardiac ejection fraction of 40% or higher with proper cardiac risk assessment
- Peripheral neuropathy less than grade 2
- Undetectable hepatitis B viral load on suppressive therapy if infected
- Completed hepatitis C eradication therapy with undetectable viral load if infected
- HIV infection under effective antiretroviral therapy with undetectable viral load
- Consent to participate in specimen banking for future research
You will not qualify if you...
- Receiving polatuzumab vedotin or mosunetuzumab as part of bridging therapy
- PET-CT scan after bridging therapy showing complete remission
- CAR T-cell product not meeting FDA-approved specifications
- CAR T-cell infusion outside the 2 to 14 day window after lymphodepleting chemotherapy
- Inability to complete required PET-CT or central imaging assessment
- Zubrod performance status greater than 2
- Absolute neutrophil count less than 1.0 x 10^3/uL or recent myeloid growth factor use
- Platelet count less than 75 x 10^3/uL or recent platelet transfusion
- Elevated bilirubin, AST, or ALT beyond specified limits
- Creatinine clearance below 40 mL/min
- Peripheral neuropathy grade 2 or higher
- Cardiac disease symptoms with NYHA class worse than 2B
- Active hepatitis B or C viral infection without undetectable viral load
- HIV infection without effective antiretroviral therapy or detectable viral load
- Documented myocardial infarction or unstable angina within specified recent timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 87 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
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States, 72758
Actively Recruiting
6
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
7
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, United States, 92627
Actively Recruiting
8
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
9
UCI Health Laguna Hills
Laguna Hills, California, United States, 92653
Actively Recruiting
10
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
11
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
Actively Recruiting
12
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
13
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
14
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
15
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
16
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States, 83619
Actively Recruiting
17
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States, 83642
Actively Recruiting
18
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
19
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States, 83301
Actively Recruiting
20
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
21
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
22
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Suspended
23
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
24
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
25
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
26
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
27
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
28
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
29
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
30
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
31
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Actively Recruiting
32
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
33
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
34
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
35
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
36
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
37
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
38
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
39
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, United States, 49009
Actively Recruiting
40
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States, 49444
Actively Recruiting
41
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States, 49120
Actively Recruiting
42
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States, 49444
Actively Recruiting
43
Corewell Health Reed City Hospital
Reed City, Michigan, United States, 49677
Actively Recruiting
44
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
45
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, United States, 48075
Active, Not Recruiting
46
Munson Medical Center
Traverse City, Michigan, United States, 49684
Actively Recruiting
47
University of Michigan Health - West
Wyoming, Michigan, United States, 49519
Actively Recruiting
48
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
49
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
50
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
51
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Suspended
52
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
53
Wilmot Cancer Institute at Webster
Webster, New York, United States, 14580
Actively Recruiting
54
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
55
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Actively Recruiting
56
Duke University Medical Center
Durham, North Carolina, United States, 27710
Suspended
57
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
58
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
59
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
60
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
61
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
62
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
63
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
64
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
65
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
66
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
67
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
68
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
69
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
70
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States, 29316
Actively Recruiting
71
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
72
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Actively Recruiting
73
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Actively Recruiting
74
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Actively Recruiting
75
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Actively Recruiting
76
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Actively Recruiting
77
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Actively Recruiting
78
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States, 38120
Actively Recruiting
79
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
80
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
81
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
Actively Recruiting
82
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
83
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
84
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
85
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
86
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
87
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
Research Team
E
Erin Rogers
CONTACT
D
Dana Sparks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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