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

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....

Conditions

• Lymphoma
• Non-Hodgkin Lymphoma
• Diffuse Large B-Cell Lymphoma
• Burkitt Lymphoma

Interventions

BIOLOGICAL

Polatuzumab

administered intravenously, on day 2, at varying doses of 1.4-1.8 mg/kg (based upon assigned dose level); every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

ibrutinib

administered orally, days 1-14, at a dose of 560 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

venetoclax

administered orally, days 2-14, at a dose of 800 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

Revlimid

administered orally, days 1 and 14, at a dose of 15 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

BIOLOGICAL

obinutuzumab

administered intravenously, days 1 and 2, at a dose of 1000 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

prednisone

administered orally, days 1-7, at a dose of 100 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Christopher J Melani, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-09

Primary Completion

2026-06-18

Completion

2031-06-18

FDA Drug

Yes

Countries

• United States

Study Locations