Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

Recruiting now · Phase 2

Conditions studied: High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified, Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified, Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

In brief

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Key facts

Study ID

NCT06649812

Run by

National Cancer Institute (NCI)

People needed

120

Starts

2025-10-07

Expected to finish

2027-09-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States (enrolling)
• Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States (enrolling)
• McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States (enrolling)
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
• Essentia Health Cancer Center — Duluth, Minnesota, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States (enrolling)
• McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States (enrolling)
• Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States (enrolling)
• Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States (enrolling)
• Essentia Health - Deer River Clinic — Deer River, Minnesota, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States (enrolling)
• Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States (enrolling)
• Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States (enrolling)
• Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States (enrolling)
• Mary Greeley Medical Center — Ames, Iowa, United States (enrolling)
• McFarland Clinic - Ames — Ames, Iowa, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Northwestern Medicine Oak Brook — Oak Brook, Illinois, United States (enrolling)
• Northwestern Medicine Orland Park — Orland Park, Illinois, United States (enrolling)
• Memorial Hospital East — Shiloh, Illinois, United States (enrolling)
• Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States (enrolling)
• Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States (enrolling)
• Essentia Health Sandstone — Sandstone, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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