Study on Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) for Treating B-cell Lymphoma That Has Returned or Not Improved

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03223610

Provider View

This clinical trial is testing a combination of five drugs, known as ViPOR, to see if they are safe and effective in treating B-cell lymphoma that has come back or not responded to previous treatments. The study is open to adults aged 18 and older.

Patient Parameters

Program Overview

B-cell lymphoma is a type of cancer that affects white blood cells in the lymph nodes, which are part of the body's immune system. This study is exploring how a combination of five drugs—venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR)—works together to treat B-cell lymphomas that have returned or not improved after treatment. The main goal is to determine the safety of this drug combination for people with B-cell lymphoma.

Description

This study involves a combination of drugs called ViPOR, which includes venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide. These drugs target different pathways that help B-cell lymphoma cells survive. The study is divided into two phases:

  • Phase 1b: This phase aims to find the safest dose of ViPOR and understand its side effects in patients with relapsed or refractory B-cell lymphoma.
  • Phase 2: This phase will assess how well ViPOR works in shrinking tumors and improving patient outcomes.

Participants will receive ViPOR in cycles of 21 days, for up to 6 cycles. During each cycle, one drug is given by IV on days 1 and 2, while the other four drugs are taken by mouth on most days. Participants will be closely monitored with regular physical exams, blood and urine tests, and imaging scans to track their response to the treatment.

After completing the treatment cycles, participants will have follow-up visits about one month after their last dose, then every few months for three years, and once a year for years four and five. These visits will include physical exams, blood tests, and scans to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Diagnosed with B-cell lymphoma that has returned or not improved after treatment.
  • Must have a specific type of B-cell lymphoma, such as Diffuse Large B-cell Lymphoma (DLBCL) or Mantle Cell Lymphoma (MCL).
  • Must have measurable disease, meaning the cancer can be seen and measured on scans or through other tests.
  • Must have adequate organ function, unless the dysfunction is due to lymphoma.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a specified period after treatment.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Currently receiving other investigational treatments.
  • Have had chemotherapy, radiation, or certain other cancer treatments within a specified time before starting the study.
  • Have had more than one of the study drugs before, except for prednisone or anti-CD20 antibody treatment.
  • Have had a stem cell or organ transplant within the last six months.
  • Have not recovered from side effects of previous cancer treatments.
  • Require the use of warfarin or certain other medications that may interact with the study drugs.
  • Have uncontrolled illnesses, such as heart failure or active infections.
  • Pregnant or breastfeeding women.
  • HIV-positive patients due to potential drug interactions and increased risk of infections.
  • Have a history of other active cancers that could interfere with the study.
  • Known allergy to study drugs or related medications.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.