New drug cocktail ViPOR targets tough lymphomas in phase II trial
NCT ID NCT06649812
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 18 times
Summary
This phase II trial is testing a combination of five drugs (venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide, called ViPOR) in people with certain aggressive B-cell lymphomas that have come back or not responded to treatment. The study aims to see how many patients achieve a complete response, meaning all signs of cancer disappear. About 120 adults will take part, and the trial is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ViPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide)
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat lymphomas that have come back or not responded to prior therapy.
- What could go wrong
- This is a phase II trial with only 120 participants, so results are preliminary. The drug combination may cause side effects and may not work for everyone.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patient must be ≥ 18 years of age * Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows: * Cohort 1: CD10-negative DLBCL, which includes: * CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-/BCL6- or CD10-/BCL6+/MUM1+ DLBCL) * CD10-negative GCB DLBCL, NOS (i.e., CD10-/BCL6+/MUM1- DLBCL) * CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6) * CD10-negative HGBCL, NOS (without MYC and BCL2 translocations) * CD10-negative T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL) OR * Cohort 2: CD10-positive or negative HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2) * NOTE: The site principal investigator must review and verify the pathology report findings to ensure the patient is eligible and is assigned to the respective cohort at the time of registration * Patient must have relapsed and/or refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen * Patient must not have confirmed or suspected primary mediastinal large B-cell lymphoma (PMBL) * Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used. * All patients of childbearing potential must have a serum or urine study with a sensitivity of at least 25 mIU/mL within 14 days prior to registration to rule out pregnancy and again within 24 hours prior to starting cycle 1 day 1 of treatment. * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patients of childbearing potential must not expect to conceive children by abstaining from sexual intercourse or by using accepted and effective methods of contraception throughout the entire duration of protocol treatment, including during dose interruptions, and for 6 months after the last dose of protocol treatment. Male patients must not father children by abstaining from sexual intercourse or by using a condom during sexual contact with pregnant partners or partners of childbearing potential throughout the entire duration of protocol treatment, including dose interruptions, and for 6 months after the last dose of protocol treatment even if they have had a successful vasectomy * Male patients must agree to not donate semen or sperm during the entire duration of protocol treatment or for at least 28 days after the last dose of lenalidomide * Patient must agree to abstain from breastfeeding during the entire duration of protocol treatment and for at least 6 months after the last dose of protocol treatment * Patient must agree to abstain from donating blood during the entire duration of protocol treatment and for at least 28 days after the last dose of lenalidomide * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Absolute neutrophil count (ANC) ≥ 1,000/mcL without requirement for granulocyte colony stimulating factor (G-CSF) support (obtained ≤ 7 days prior to registration) * Hemoglobin ≥ 8 g/dL (obtained ≤ 7 days prior to registration) * Platelets ≥ 75,000/mcL without requirement for platelet transfusion support (obtained ≤ 7 days prior to registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome) (obtained ≤ 7 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 7 days prior to registration) * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m\^2 (estimated by Cockcroft-Gault method or measured) (obtained ≤ 7 days prior to registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patient must not have confirmed or suspected primary DLBCL of the central nervous system (CNS) (PCNSL) * Patients with history of secondary CNS lymphoma (SCNSL) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must not have taken or require warfarin or other strong CYP3A inhibitors or inducers within 7 days prior to registration. * NOTE: Antiplatelet agents, other anticoagulants aside from warfarin, as well as mild or moderate CYP3A inhibitors or inducers are permitted on study but should be used with caution * Patient must not have an uncontrolled intercurrent illness that would interfere with the safety or efficacy assessment of this protocol * Patient must not have evidence of an active infection at the time of registration * Patient must not have the following current or prior anti-cancer treatment: * Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration * NOTE: Short courses of corticosteroids or palliative external beam radiation therapy (XRT) prior to registration are permitted * More than 3 prior lines of cytotoxic chemotherapy, excluding targeted therapy, anti-cancer antibodies, antibody-drug conjugates, bi-specific antibodies, and radio- or toxin-immunoconjugates * NOTE: Cytoreductive chemotherapy followed by autologous stem cell transplant (ASCT) counts as 1 line of cytotoxic therapy. Similarly, cytoreductive chemotherapy (either pre-T-cell collection or as bridging therapy) followed by pre-conditioning therapy/chimeric antigen receptor T-cell (CAR-T) counts as 1 line of therapy, as long as no disease progression occurs between interventions. For both therapies, if progressive disease is documented between 2 distinct regimens, then they should be counted as 2 lines of cytotoxic chemotherapy * Radio- or toxin-immunoconjugates within 10 weeks prior to registration * Previous treatment with more than one of the following study agents: venetoclax (or another BCL2 inhibitor), ibrutinib (or another BTK inhibitor), or lenalidomide (or another immunomodulatory imide drug \[IMiD\]) * Prior autologous stem cell transplant (ASCT), chimeric antigen receptor T-cell (CAR-T) therapy, or allogeneic stem cell (or other organ) transplant within 3 months prior to registration * Any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration * NOTE: In addition, patient must have recovered (i.e., ≤ grade 1 or baseline) from all adverse events due to previously administered anti-cancer treatment, surgery, or procedure * NOTE: Exceptions to this include events not considered to place the patient at unacceptable risk of participation in the opinion of the treating investigator (i.e., alopecia) * Patients 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 * Patient must have adequate formalin fixed paraffin embedded (FFPE) tumor tissue specimen from the initial diagnostic biopsy or on-study repeat tumor tissue biopsy for molecular analysis * NOTE: Excisional tumor biopsy is preferred. Core needle biopsies will be considered adequate if there is enough tissue for the mandatory molecular analysis. Submission of an entire FFPE tumor block is preferred, but if unavailable 10 x 10um FFPE scrolls may be submitted as an alternative. If adequate archived FFPE tumor tissue is unavailable, the patient must be willing to undergo research biopsy for molecular analysis * Patient must have measurable disease * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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Get notified about this study
Sign up to get updates when this study changes or when new studies for High grade B-cell lymphoma with MYC and BCL6 rearrangements are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
96 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Aultman Health Foundation
RECRUITINGCanton, Ohio, 44710, United States
Contact Email: •••••@•••••
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Banner University Medical Center - Tucson
RECRUITINGTucson, Arizona, 85719, United States
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Benefis Sletten Cancer Institute
RECRUITINGGreat Falls, Montana, 59405, United States
Contact Email: •••••@•••••
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Billings Clinic Cancer Center
RECRUITINGBillings, Montana, 59101, United States
Contact Email: •••••@•••••
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Bozeman Health Deaconess Hospital
RECRUITINGBozeman, Montana, 59715, United States
Contact Email: •••••@•••••
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Carle BroMenn Medical Center
RECRUITINGNormal, Illinois, 61761, United States
Contact Email: •••••@•••••
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Carle Cancer Center
RECRUITINGUrbana, Illinois, 61801, United States
Contact Email: •••••@•••••
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Carle Cancer Institute Normal
RECRUITINGNormal, Illinois, 61761, United States
Contact Email: •••••@•••••
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Carle Physician Group-Effingham
RECRUITINGEffingham, Illinois, 62401, United States
Contact Email: •••••@•••••
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Carle Physician Group-Mattoon/Charleston
RECRUITINGMattoon, Illinois, 61938, United States
Contact Email: •••••@•••••
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Carle at The Riverfront
RECRUITINGDanville, Illinois, 61832, United States
Contact Email: •••••@•••••
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
Contact Email: •••••@•••••
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Community Hospital of Anaconda
RECRUITINGAnaconda, Montana, 59711, United States
Contact Email: •••••@•••••
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Community Medical Center
RECRUITINGMissoula, Montana, 59804, United States
Contact Email: •••••@•••••
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Drexel Town Square Health Center
RECRUITINGOak Creek, Wisconsin, 53154, United States
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Duluth Clinic Ashland
RECRUITINGAshland, Wisconsin, 54806, United States
Contact Email: •••••@•••••
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Essentia Health - Deer River Clinic
RECRUITINGDeer River, Minnesota, 56636, United States
Contact Email: •••••@•••••
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Essentia Health Cancer Center
RECRUITINGDuluth, Minnesota, 55805, United States
Contact Email: •••••@•••••
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Essentia Health Cancer Center-South University Clinic
RECRUITINGFargo, North Dakota, 58103, United States
Contact Email: •••••@•••••
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Essentia Health Hibbing Clinic
RECRUITINGHibbing, Minnesota, 55746, United States
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Essentia Health Saint Joseph's Medical Center
RECRUITINGBrainerd, Minnesota, 56401, United States
Contact Email: •••••@•••••
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Essentia Health Saint Mary's Hospital - Superior
RECRUITINGSuperior, Wisconsin, 54880, United States
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Essentia Health Sandstone
RECRUITINGSandstone, Minnesota, 55072, United States
Contact Email: •••••@•••••
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Essentia Health Virginia Clinic
RECRUITINGVirginia, Minnesota, 55792, United States
Contact Email: •••••@•••••
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Essentia Health-Spooner Clinic
RECRUITINGSpooner, Wisconsin, 54801, United States
Contact Email: •••••@•••••
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Froedtert Menomonee Falls Hospital
RECRUITINGMenomonee Falls, Wisconsin, 53051, United States
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Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITINGWest Bend, Wisconsin, 53095, United States
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Froedtert and MCW Moorland Reserve Health Center
RECRUITINGNew Berlin, Wisconsin, 53151, United States
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Gundersen Lutheran Medical Center
RECRUITINGLa Crosse, Wisconsin, 54601, United States
Contact Email: •••••@•••••
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Kootenai Clinic Cancer Services - Post Falls
RECRUITINGPost Falls, Idaho, 83854, United States
Contact Email: •••••@•••••
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Kootenai Clinic Cancer Services - Sandpoint
RECRUITINGSandpoint, Idaho, 83864, United States
Contact Email: •••••@•••••
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Kootenai Health - Coeur d'Alene
RECRUITINGCoeur d'Alene, Idaho, 83814, United States
Contact Email: •••••@•••••
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Logan Health Medical Center
RECRUITINGKalispell, Montana, 59901, United States
Contact Email: •••••@•••••
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Mary Greeley Medical Center
RECRUITINGAmes, Iowa, 50010, United States
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McFarland Clinic - Ames
RECRUITINGAmes, Iowa, 50010, United States
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McFarland Clinic - Boone
SUSPENDEDBoone, Iowa, 50036, United States
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McFarland Clinic - Jefferson
SUSPENDEDJefferson, Iowa, 50129, United States
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McFarland Clinic - Marshalltown
RECRUITINGMarshalltown, Iowa, 50158, United States
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McFarland Clinic - Trinity Cancer Center
RECRUITINGFort Dodge, Iowa, 50501, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Memorial Hospital East
RECRUITINGShiloh, Illinois, 62269, United States
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Mercy Hospital
RECRUITINGCedar Rapids, Iowa, 52403, United States
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Mercyhealth Hospital and Cancer Center - Janesville
RECRUITINGJanesville, Wisconsin, 53548, United States
Contact Email: •••••@•••••
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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Nebraska Medicine-Bellevue
RECRUITINGBellevue, Nebraska, 68123, United States
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Nebraska Medicine-Village Pointe
RECRUITINGOmaha, Nebraska, 68118, United States
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Northwest Cancer Center - Crown Point
RECRUITINGCrown Point, Indiana, 46307, United States
Contact Email: •••••@•••••
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Northwest Cancer Center - Valparaiso
RECRUITINGValparaiso, Indiana, 46383, United States
Contact Email: •••••@•••••
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Northwest Oncology LLC
RECRUITINGDyer, Indiana, 46311, United States
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Northwestern Medicine Cancer Center Delnor
RECRUITINGGeneva, Illinois, 60134, United States
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Northwestern Medicine Cancer Center Kishwaukee
RECRUITINGDeKalb, Illinois, 60115, United States
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Northwestern Medicine Cancer Center Warrenville
RECRUITINGWarrenville, Illinois, 60555, United States
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Northwestern Medicine Glenview Outpatient Center
RECRUITINGGlenview, Illinois, 60026, United States
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Northwestern Medicine Grayslake Outpatient Center
RECRUITINGGrayslake, Illinois, 60030, United States
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Northwestern Medicine Lake Forest Hospital
RECRUITINGLake Forest, Illinois, 60045, United States
Contact Email: •••••@•••••
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Northwestern Medicine Oak Brook
RECRUITINGOak Brook, Illinois, 60523, United States
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Northwestern Medicine Orland Park
RECRUITINGOrland Park, Illinois, 60462, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
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Ochsner Medical Center Jefferson
RECRUITINGNew Orleans, Louisiana, 70121, United States
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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Oncology Associates at Mercy Medical Center
RECRUITINGCedar Rapids, Iowa, 52403, United States
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ProHealth D N Greenwald Center
RECRUITINGMukwonago, Wisconsin, 53149, United States
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ProHealth Oconomowoc Memorial Hospital
RECRUITINGOconomowoc, Wisconsin, 53066, United States
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Providence Newberg Medical Center
SUSPENDEDNewberg, Oregon, 97132, United States
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Providence Portland Medical Center
RECRUITINGPortland, Oregon, 97213, United States
Contact Email: •••••@•••••
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Providence Saint Vincent Medical Center
RECRUITINGPortland, Oregon, 97225, United States
Contact Email: •••••@•••••
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Providence Willamette Falls Medical Center
SUSPENDEDOregon City, Oregon, 97045, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Saint Catherine Hospital
RECRUITINGIndianapolis, Indiana, 46312, United States
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Saint Mary Medical Center
RECRUITINGHobart, Indiana, 46342, United States
Contact Email: •••••@•••••
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Siteman Cancer Center at Christian Hospital
RECRUITINGSt Louis, Missouri, 63136, United States
Contact Email: •••••@•••••
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Siteman Cancer Center at Saint Peters Hospital
RECRUITINGCity of Saint Peters, Missouri, 63376, United States
Contact Email: •••••@•••••
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Siteman Cancer Center at West County Hospital
RECRUITINGCreve Coeur, Missouri, 63141, United States
Contact Email: •••••@•••••
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Siteman Cancer Center-South County
RECRUITINGSt Louis, Missouri, 63129, United States
Contact Email: •••••@•••••
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Smilow Cancer Hospital Care Center - Guilford
RECRUITINGGuilford, Connecticut, 06437, United States
Contact Email: •••••@•••••
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Smilow Cancer Hospital-Derby Care Center
RECRUITINGDerby, Connecticut, 06418, United States
Contact Email: •••••@•••••
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Swedish Medical Center-First Hill
RECRUITINGSeattle, Washington, 98122, United States
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The Community Hospital
RECRUITINGMunster, Indiana, 46321, United States
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Thomas Jefferson University Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
Contact Email: •••••@•••••
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UW Cancer Center at ProHealth Care
RECRUITINGWaukesha, Wisconsin, 53188, United States
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University of Arizona Cancer Center-North Campus
RECRUITINGTucson, Arizona, 85719, United States
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University of Cincinnati Cancer Center-UC Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Email: •••••@•••••
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University of Cincinnati Cancer Center-West Chester
RECRUITINGWest Chester, Ohio, 45069, United States
Contact Email: •••••@•••••
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Vermont Medical Center
RECRUITINGBurlington, Vermont, 05401, United States
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University of Vermont and State Agricultural College
RECRUITINGBurlington, Vermont, 05405, United States
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University of Virginia Cancer Center
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITINGMadison, Wisconsin, 53718, United States
Contact Email: •••••@•••••
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University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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VCU Massey Comprehensive Cancer Center
RECRUITINGRichmond, Virginia, 23298, United States
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Walter Reed National Military Medical Center
RECRUITINGBethesda, Maryland, 20889-5600, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
Contact Email: •••••@•••••
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Women's Diagnostic Center - Munster
RECRUITINGMunster, Indiana, 46321, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Multi-Drug combo outsmart resistant lymphoma?
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- Radiation boost may supercharge CAR T-Cell therapy against tough lymphoma
- New combo approach aims to boost CAR-T success in tough lymphoma
- New combo attack on lymphoma shows promise in early trial