Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

• Status: Recruiting
• Trial end date: 2027-05-01

Summary

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....

• Phase: Phase 1

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Lenalidomide; Obinutuzumab; Prednisone; Venetoclax