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New drug cocktail ViPOR targets tough lymphomas in phase II trial

NCT ID NCT06649812

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    96 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Aultman Health Foundation

    RECRUITING

    Canton, Ohio, 44710, United States

    Contact Email: •••••@•••••

  • Banner University Medical Center - Tucson

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Benefis Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Bozeman Health Deaconess Hospital

    RECRUITING

    Bozeman, Montana, 59715, United States

    Contact Email: •••••@•••••

  • Carle BroMenn Medical Center

    RECRUITING

    Normal, Illinois, 61761, United States

    Contact Email: •••••@•••••

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Cancer Institute Normal

    RECRUITING

    Normal, Illinois, 61761, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Community Hospital of Anaconda

    RECRUITING

    Anaconda, Montana, 59711, United States

    Contact Email: •••••@•••••

  • Community Medical Center

    RECRUITING

    Missoula, Montana, 59804, United States

    Contact Email: •••••@•••••

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Duluth Clinic Ashland

    RECRUITING

    Ashland, Wisconsin, 54806, United States

    Contact Email: •••••@•••••

  • Essentia Health - Deer River Clinic

    RECRUITING

    Deer River, Minnesota, 56636, United States

    Contact Email: •••••@•••••

  • Essentia Health Cancer Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Essentia Health Cancer Center-South University Clinic

    RECRUITING

    Fargo, North Dakota, 58103, United States

    Contact Email: •••••@•••••

  • Essentia Health Hibbing Clinic

    RECRUITING

    Hibbing, Minnesota, 55746, United States

  • Essentia Health Saint Joseph's Medical Center

    RECRUITING

    Brainerd, Minnesota, 56401, United States

    Contact Email: •••••@•••••

  • Essentia Health Saint Mary's Hospital - Superior

    RECRUITING

    Superior, Wisconsin, 54880, United States

  • Essentia Health Sandstone

    RECRUITING

    Sandstone, Minnesota, 55072, United States

    Contact Email: •••••@•••••

  • Essentia Health Virginia Clinic

    RECRUITING

    Virginia, Minnesota, 55792, United States

    Contact Email: •••••@•••••

  • Essentia Health-Spooner Clinic

    RECRUITING

    Spooner, Wisconsin, 54801, United States

    Contact Email: •••••@•••••

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • Froedtert and MCW Moorland Reserve Health Center

    RECRUITING

    New Berlin, Wisconsin, 53151, United States

  • Gundersen Lutheran Medical Center

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Post Falls

    RECRUITING

    Post Falls, Idaho, 83854, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Sandpoint

    RECRUITING

    Sandpoint, Idaho, 83864, United States

    Contact Email: •••••@•••••

  • Kootenai Health - Coeur d'Alene

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

    Contact Email: •••••@•••••

  • Logan Health Medical Center

    RECRUITING

    Kalispell, Montana, 59901, United States

    Contact Email: •••••@•••••

  • Mary Greeley Medical Center

    RECRUITING

    Ames, Iowa, 50010, United States

  • McFarland Clinic - Ames

    RECRUITING

    Ames, Iowa, 50010, United States

  • McFarland Clinic - Boone

    SUSPENDED

    Boone, Iowa, 50036, United States

  • McFarland Clinic - Jefferson

    SUSPENDED

    Jefferson, Iowa, 50129, United States

  • McFarland Clinic - Marshalltown

    RECRUITING

    Marshalltown, Iowa, 50158, United States

  • McFarland Clinic - Trinity Cancer Center

    RECRUITING

    Fort Dodge, Iowa, 50501, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Hospital East

    RECRUITING

    Shiloh, Illinois, 62269, United States

  • Mercy Hospital

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Mercyhealth Hospital and Cancer Center - Janesville

    RECRUITING

    Janesville, Wisconsin, 53548, United States

    Contact Email: •••••@•••••

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • Nebraska Medicine-Bellevue

    RECRUITING

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine-Village Pointe

    RECRUITING

    Omaha, Nebraska, 68118, United States

  • Northwest Cancer Center - Crown Point

    RECRUITING

    Crown Point, Indiana, 46307, United States

    Contact Email: •••••@•••••

  • Northwest Cancer Center - Valparaiso

    RECRUITING

    Valparaiso, Indiana, 46383, United States

    Contact Email: •••••@•••••

  • Northwest Oncology LLC

    RECRUITING

    Dyer, Indiana, 46311, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Glenview Outpatient Center

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Northwestern Medicine Grayslake Outpatient Center

    RECRUITING

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    RECRUITING

    Lake Forest, Illinois, 60045, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Oak Brook

    RECRUITING

    Oak Brook, Illinois, 60523, United States

  • Northwestern Medicine Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Ochsner Medical Center Jefferson

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • ProHealth D N Greenwald Center

    RECRUITING

    Mukwonago, Wisconsin, 53149, United States

  • ProHealth Oconomowoc Memorial Hospital

    RECRUITING

    Oconomowoc, Wisconsin, 53066, United States

  • Providence Newberg Medical Center

    SUSPENDED

    Newberg, Oregon, 97132, United States

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Providence Willamette Falls Medical Center

    SUSPENDED

    Oregon City, Oregon, 97045, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Saint Catherine Hospital

    RECRUITING

    Indianapolis, Indiana, 46312, United States

  • Saint Mary Medical Center

    RECRUITING

    Hobart, Indiana, 46342, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Guilford

    RECRUITING

    Guilford, Connecticut, 06437, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Derby Care Center

    RECRUITING

    Derby, Connecticut, 06418, United States

    Contact Email: •••••@•••••

  • Swedish Medical Center-First Hill

    RECRUITING

    Seattle, Washington, 98122, United States

  • The Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • UW Cancer Center at ProHealth Care

    RECRUITING

    Waukesha, Wisconsin, 53188, United States

  • University of Arizona Cancer Center-North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Vermont and State Agricultural College

    RECRUITING

    Burlington, Vermont, 05405, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Walter Reed National Military Medical Center

    RECRUITING

    Bethesda, Maryland, 20889-5600, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Women's Diagnostic Center - Munster

    RECRUITING

    Munster, Indiana, 46321, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

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