OncoMatch/Clinical Trials/NCT04739813
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
Is NCT04739813 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for lymphoma.
Treatment: obinutuzumab · prednisone · Revlimid · Polatuzumab · ibrutinib · venetoclax — Background: Aggressive B-cell lymphomas can be cured but people with disease that resists treatment or that returns after treatment have poor outcomes with standard therapies. Indolent B-cell lymphomas are generally incurable with standard therapy and treatment is aimed at controlling symptoms and achieving a durable remissions. Researchers want to see if a combination of drugs can help patients with both aggressive and indolent B-cell lymphomas. Objective: To learn if it is safe and effective to give polatuzumab along with venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide to people with certain B-cell lymphomas. Eligibility: Adults ages 18 and older with relapsed and/or refractory B-cell lymphoma who have had at least one prior cancer treatment. Design: Participants will be screened with: Medical history Physical exam Assessment of how they do their daily activities Blood and urine tests Heart function test Tissue biopsy (if needed) Body imaging scans (may get a contrast agent through an intravenous (IV) catheter) Participants will have a bone marrow aspiration and/or biopsy. A needle will be put into the hipbone. Bone marrow will be removed. Participants may give blood, tissue, saliva, or cheek swab samples. They may have optional biopsies. Screening tests will be repeated during the study. Treatment will be given for up to 6 cycles. Each cycle lasts 21 days. Participants will take venetoclax and prednisone tablets by mouth. They will take ibrutinib and lenalidomide capsules by mouth. They will get obinutuzumab and polatuzumab by IV infusion. They will keep a medicine diary. Participants will visit the clinic 30 days after treatment ends. They will have follow-up visits for 5 years. If needed, they can visit their local doctor instead. They may be contacted by phone, mail, etc., for the rest of their life....
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-containing regimen — 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-containing regimen — 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: chemotherapy or anti-cancer antibodies
Exception: Short courses of corticosteroids or palliative XRT prior to enrollment are permitted within the 2-week washout period.
Any chemotherapy or anti-cancer antibodies within 2 weeks
Cannot have received: radio- or toxin-immunoconjugates
Radio- or toxin-immunoconjugates within 10 weeks
Cannot have received: study agents (polatuzumab, venetoclax, ibrutinib, Revlimid) (polatuzumab, venetoclax, ibrutinib, Revlimid)
Exception: excluding prior prednisone or anti-CD20 antibody treatment
Previous treatment with more than one of the study agents (i.e., polatuzumab, venetoclax, ibrutinib, or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment
Cannot have received: allogeneic stem cell (or other organ) transplant
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
Lab requirements
Blood counts
absolute neutrophil count >=1,000/mcL; hemoglobin >=8 g/dL; Platelets >=75,000/mcL; INR <=1.5 X institutional ULN for patients not receiving therapeutic anticoagulation; PTT/aPTT <=1.5 X institutional ULN except if, in the opinion of the investigator, the aPTT is elevated because of a positive Lupus Anticoagulant, or a significant bleeding risk has been ruled out in the absence of a positive Lupus Anticoagulant
Kidney function
Serum creatinine <=2.0 mg/dL OR Creatinine clearance >=30 mL/min/1.73 m2 for patients with creatinine levels above 2 mg/dL
Liver function
total bilirubin <=1.5 X institutional ULN (or <=3 X institutional ULN for patients with documented Gilberts syndrome); AST(SGOT)/ALT(SGPT) <=3 X institutional 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
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