OncoMatch/Clinical Trials/NCT03223610
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Is NCT03223610 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for lymphoma.
Treatment: Venetoclax · Ibrutinib · Prednisone · Obinutuzumab · Revlimid (lenalidomide) — Background: B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR). Objective: To study the safety of ViPOR for people with B-cell lymphoma. Eligibility: People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Tissue sample from previous procedure * Imaging scans * Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days. Participants will have a bone marrow aspiration before treatment. Participants may have tumor samples taken. Participants will get ViPOR in 21-day cycles. For up to 6 cycles: * Participants will get one drug by IV on days 1 and 2. * Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring. Participants will keep a drug diary. Participants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles. Participants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans....
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Allowed: BCL2 rearrangement
Allowed: BCL6 rearrangement
Allowed: MYC rearrangement
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline — aggressive B-cell lymphoma
Aggressive B-cell lymphoma: relapsed after and/or refractory to at least 1 prior anthracycline-containing regimen
Must have received: anti-CD20 antibody — indolent B-cell lymphoma
Indolent B-cell lymphoma: relapsed after and/or refractory to at least 1 prior anti-CD20 antibody-containing regimen.
Cannot have received: venetoclax
Exception: no more than one prior study agent (venetoclax, ibrutinib, or Revlimid), excluding prior prednisone or anti-CD20 antibody treatment
Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment
Cannot have received: ibrutinib
Exception: no more than one prior study agent (venetoclax, ibrutinib, or Revlimid), excluding prior prednisone or anti-CD20 antibody treatment
Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment
Cannot have received: lenalidomide (Revlimid)
Exception: no more than one prior study agent (venetoclax, ibrutinib, or Revlimid), excluding prior prednisone or anti-CD20 antibody treatment
Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment
Cannot have received: allogeneic stem cell transplant
Exception: allowed if >6 months prior and no active GVHD or immunosuppressants within 28 days
Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug
Cannot have received: chemotherapy
Exception: allowed if >2 weeks prior
Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug
Cannot have received: external beam radiation therapy
Exception: allowed if >2 weeks prior
Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug
Cannot have received: anti-cancer antibody
Exception: allowed if >2 weeks prior
Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug
Cannot have received: radioimmunoconjugate
Exception: allowed if >10 weeks prior
Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug
Cannot have received: toxin-immunoconjugate
Exception: allowed if >10 weeks prior
Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug
Lab requirements
Blood counts
ANC ≥ 1,000/mcL (RBC transfusions and use of G-CSF allowed); hemoglobin ≥ 8 g/dL (RBC transfusions and use of G-CSF allowed); platelets ≥ 75,000/mcL; INR ≤ 1.5 x ULN for patients not receiving therapeutic anticoagulation; PTT/aPTT ≤ 1.5 x ULN except if elevated due to positive Lupus Anticoagulant
Kidney function
Serum Creatinine: ≤ 2.0 mg/dL OR Creatinine Clearance: ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above 2 mg/dL
Liver function
Total Bilirubin: ≤ 1.5 x ULN (or ≤ 3 x ULN for Gilbert's syndrome); AST(SGOT)/ALT(SGPT): ≤ 2.5 x ULN
Adequate organ and marrow function as defined below unless dysfunction is secondary to lymphoma
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify