Actively Recruiting
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-04-29
55
Participants Needed
1
Research Sites
518 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically or cytologically confirmed relapsed or refractory B-cell lymphoma (excluding mantle cell lymphoma and CLL/SLL)
- Aggressive B-cell lymphoma including DLBCL, transformed lymphoma, Burkitt lymphoma, or high-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangements
- Indolent B-cell lymphoma (excluding MCL and CLL/SLL)
- Non-GCB DLBCL for expansion cohort
- Relapsed/refractory disease after at least one prior treatment (anthracycline-containing regimen for aggressive lymphoma or anti-CD20 antibody for indolent lymphoma)
- ECOG performance status 0 to 2
- Adequate organ and marrow function unless due to lymphoma
- Ability to understand and willing to sign informed consent
- Agreement to use effective contraception if of childbearing potential or able to father a child
You will not qualify if you...
- Active treatment with other investigational agents
- Chemotherapy or anticancer antibodies within 2 weeks prior to study drug
- Radio- or toxin-immunoconjugates within 10 weeks
- Prior treatment with more than one of the study agents (polatuzumab, venetoclax, ibrutinib, or Revlimid), excluding prednisone or anti-CD20 antibodies
- Recent allogeneic stem cell or organ transplant within 6 months or active graft-versus-host disease
- Not recovered from prior treatment-related adverse events (except alopecia)
- Need for warfarin or strong CYP3A inhibitors/inducers near study start
- Uncontrolled illness including symptomatic heart failure, unstable angina, uncontrolled arrhythmia, thyroid disease, active infection, liver disease, malabsorption, or psychiatric illness
- Pregnant or intending to become pregnant
- HIV positive
- Active tumor lysis syndrome
- Recent major surgery within 6 weeks (except diagnosis)
- History of other active malignancy affecting compliance or results
- Allergy to study drugs or related agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
CONTACT
C
Christopher J Melani, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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