OncoMatch/Clinical Trials/NCT03223610
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Is NCT03223610 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
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)
Demographics
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 →Frequently asked questions
Is NCT03223610 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior venetoclax, ibrutinib, lenalidomide disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
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