Actively Recruiting
A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) for Relapsed or Refractory CD10-Negative Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
Led by National Cancer Institute (NCI) ยท Updated on 2026-05-13
120
Participants Needed
83
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination targeted therapy called ViPOR, which includes venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid, for patients with relapsed or refractory CD10-negative diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma with MYC and BCL2 rearrangements. This Phase II study aims to measure how well ViPOR induces a complete response and assesses other outcomes such as overall response, survival rates, and safety in these aggressive lymphomas. The study also explores molecular subtypes and biomarkers to understand treatment response and resistance better. Patients receive ViPOR treatment in 21-day cycles for up to six cycles if their disease does not progress and they do not experience unacceptable side effects. The treatment includes oral venetoclax on days 2 to 14, oral ibrutinib on days 1 to 14, oral prednisone on days 1 to 7, intravenous obinutuzumab on days 1 and 2, and oral Revlimid on days 1 to 14. Throughout the study, participants may undergo blood tests, imaging scans like PET, CT, or MRI, and optional tumor and bone marrow biopsies to monitor their disease and response. Participants are followed closely during treatment and after completing therapy. Follow-up visits occur every six months for two years, then annually for years three to five, and survival is monitored for up to ten years from registration. Researchers assess treatment effectiveness through complete response rates and other measures such as duration of response, event-free survival, progression-free survival, and overall survival. Safety and side effects are also closely monitored to understand the therapy's impact over time.
CONDITIONS
Brief Title
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older
- Diagnosis of aggressive B-cell lymphoma including: CD10-negative diffuse large B-cell lymphoma (DLBCL), CD10-negative high-grade B-cell lymphoma with MYC and BCL6 rearrangements, CD10-negative T-cell/histiocyte-rich large B-cell lymphoma, or CD10-positive/negative high-grade B-cell lymphoma with MYC and BCL2 rearrangements
- Relapsed or refractory disease after at least one prior anthracycline and anti-CD20 antibody-containing treatment
- No confirmed or suspected primary mediastinal large B-cell lymphoma
- Not pregnant and agrees to pregnancy testing and use of effective contraception if of childbearing potential
- Willing to abstain from breastfeeding and blood donation during treatment and specified periods afterward
- Ability to understand and willing to sign informed consent
- Adequate blood counts and organ function within 7 days prior to registration
- HIV-positive patients on effective therapy with undetectable viral load are eligible
- Patients with treated hepatitis B or C under control or cured
- No confirmed or suspected primary central nervous system lymphoma; patients with treated secondary CNS lymphoma without progression are eligible
- No use of warfarin or strong CYP3A inhibitors/inducers within 7 days prior to registration
- No uncontrolled illness or active infection at registration
- No recent anti-cancer treatment within specified timeframes
- No more than three prior lines of cytotoxic chemotherapy
- No prior treatment with more than one of venetoclax, ibrutinib, or lenalidomide
- No recent stem cell transplant, CAR-T therapy, or active graft-versus-host disease
- Cardiac function classified as New York Heart Association class 2B or better
- Adequate tumor tissue available for molecular analysis
- Measurable disease present
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
You will not qualify if you...
- Pregnancy or breastfeeding during the study
- Confirmed or suspected primary mediastinal large B-cell lymphoma
- Confirmed or suspected primary central nervous system lymphoma
- Active infection at time of registration
- Uncontrolled intercurrent illness
- Use of warfarin or strong CYP3A inhibitors or inducers within 7 days prior to registration
- More than three prior lines of cytotoxic chemotherapy
- Prior treatment with more than one of venetoclax, ibrutinib, or lenalidomide
- Stem cell transplant, CAR-T therapy, or allogeneic transplant within 3 months prior to registration
- Active graft-versus-host disease or ongoing immunosuppressant use within 28 days prior to registration
- Poor cardiac function worse than NYHA class 2B
- Inadequate tumor tissue for molecular analysis
- Eastern Cooperative Oncology Group (ECOG) performance status worse than 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 21 days each
Participants receive a combination targeted therapy including oral venetoclax, ibrutinib, prednisone, lenalidomide, and intravenous obinutuzumab in repeated 21-day cycles. They undergo blood sample collection, imaging scans (PET, CT and/or MRI), and optional tumor and bone marrow biopsies throughout treatment.
Up to 6 treatment cycles with multiple visits per cycle for medication administration, sample collection, and imaging
Duration - Up to 10 years
After completing treatment, participants are monitored for response and survival with regular follow-up visits for up to 10 years.
Visits every 6 months for 2 years, then yearly during years 3-5, and survival follow-up thereafter
Trial Site Locations
Total: 83 locations
1
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Suspended
2
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Suspended
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
5
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
6
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
7
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Suspended
8
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Suspended
9
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Suspended
10
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Carle at The Riverfront
Danville, Illinois, United States, 61832
Suspended
12
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
13
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Suspended
14
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
15
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States, 60026
Actively Recruiting
16
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States, 60030
Actively Recruiting
17
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States, 60045
Actively Recruiting
18
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Suspended
19
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Suspended
20
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Suspended
21
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States, 60523
Actively Recruiting
22
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
23
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
24
Carle Cancer Center
Urbana, Illinois, United States, 61801
Suspended
25
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
26
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
27
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
28
McFarland Clinic - Boone
Boone, Iowa, United States, 50036
Suspended
29
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
30
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
31
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
32
McFarland Clinic - Jefferson
Jefferson, Iowa, United States, 50129
Suspended
33
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States, 50158
Actively Recruiting
34
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
35
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
36
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Actively Recruiting
37
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
38
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
39
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
40
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
41
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
42
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
43
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
44
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
45
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
46
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
47
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Suspended
48
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Suspended
49
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Suspended
50
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Suspended
51
Community Medical Center
Missoula, Montana, United States, 59804
Suspended
52
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States, 68123
Actively Recruiting
53
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States, 68118
Actively Recruiting
54
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
55
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
56
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
57
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Suspended
58
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
59
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Suspended
60
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
61
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
62
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
63
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
64
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
65
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
66
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
67
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
68
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
69
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
70
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
71
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
72
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, United States, 53548
Actively Recruiting
73
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
74
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
75
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
76
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Suspended
77
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
78
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
79
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Suspended
80
Essentia Health-Spooner Clinic
Spooner, Wisconsin, United States, 54801
Actively Recruiting
81
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, United States, 54880
Actively Recruiting
82
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Suspended
83
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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