OncoMatch/Clinical Trials/NCT06649812
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
Is NCT06649812 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for high grade b-cell lymphoma with myc and bcl6 rearrangements.
Treatment: Ibrutinib · Lenalidomide · Obinutuzumab · Prednisone · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: MYC rearrangement
HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6); HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)
Required: BCL2 rearrangement
HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)
Required: BCL6 rearrangement
HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6); HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline
relapsed and/or refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen
Must have received: anti-CD20 antibody
relapsed and/or refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen
Cannot have received: cytotoxic chemotherapy
Exception: ≤ 3 prior lines allowed
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
Cannot have received: radio- or toxin-immunoconjugate
Exception: within 10 weeks prior to registration
Radio- or toxin-immunoconjugates within 10 weeks prior to registration
Cannot have received: venetoclax (venetoclax)
Exception: no more than one of venetoclax, ibrutinib, or lenalidomide
Previous treatment with more than one of the following study agents: venetoclax, ibrutinib, or lenalidomide
Cannot have received: ibrutinib (ibrutinib)
Exception: no more than one of venetoclax, ibrutinib, or lenalidomide
Previous treatment with more than one of the following study agents: venetoclax, ibrutinib, or lenalidomide
Cannot have received: lenalidomide (lenalidomide)
Exception: no more than one of venetoclax, ibrutinib, or lenalidomide
Previous treatment with more than one of the following study agents: venetoclax, ibrutinib, or lenalidomide
Cannot have received: autologous stem cell transplant
Exception: within 3 months prior to registration
Prior autologous stem cell transplant (ASCT)...within 3 months prior to registration
Cannot have received: CAR-T cell therapy
Exception: within 3 months prior to registration
chimeric antigen receptor T-cell (CAR-T) therapy...within 3 months prior to registration
Cannot have received: allogeneic stem cell transplant
Exception: within 3 months prior to registration
allogeneic stem cell (or other organ) transplant within 3 months prior to registration
Cannot have received: immunosuppressant
Exception: requirement for immunosuppressants within 28 days prior to registration
requirement for immunosuppressants within 28 days prior to registration
Cannot have received: chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies
Exception: received within 2 weeks prior to registration; short courses of corticosteroids or palliative XRT permitted
Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration
Lab requirements
Blood counts
ANC ≥ 1,000/mcL without G-CSF support; Hemoglobin ≥ 8 g/dL; Platelets ≥ 75,000/mcL without platelet transfusion support
Kidney function
Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m^2 (estimated by Cockcroft-Gault method or measured)
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome); AST/ALT ≤ 3.0 x institutional ULN
Cardiac function
NYHA class 2B or better if cardiac disease or history of cardiotoxic agents
ANC ≥ 1,000/mcL without G-CSF support; Hemoglobin ≥ 8 g/dL; Platelets ≥ 75,000/mcL without platelet transfusion support; Total bilirubin ≤ 1.5 x institutional ULN (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome); AST/ALT ≤ 3.0 x institutional ULN; Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m^2; NYHA class 2B or better if cardiac disease or history of cardiotoxic agents
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- Cedars Sinai Medical Center · Los Angeles, California
- Smilow Cancer Hospital-Derby Care Center · Derby, Connecticut
- Smilow Cancer Hospital Care Center - Guilford · Guilford, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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