Study on Rituximab and Pembrolizumab With or Without Lenalidomide for Treating Relapsed Follicular and Diffuse Large B-Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02446457

Provider View

This clinical trial is exploring how well a combination of drugs, including rituximab and pembrolizumab, with or without lenalidomide, works in treating patients whose follicular or diffuse large B-cell lymphoma has returned after previous treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if using rituximab and pembrolizumab, with or without lenalidomide, can effectively treat follicular lymphoma and diffuse large B-cell lymphoma that has come back after a period of improvement. Rituximab and pembrolizumab are immunotherapy drugs that help the immune system attack cancer cells, while lenalidomide is a chemotherapy drug that stops cancer cells from growing and spreading. The study aims to find out if this combination of treatments can work better than previous therapies.

Description

The study is divided into two groups:

  • Cohort 1: Patients receive rituximab through an IV on days 1, 8, 15, and 22, and pembrolizumab through an IV on day 2 every 3 weeks for up to 1 year, unless the disease worsens or side effects become too severe.

  • Cohort 2: Patients receive rituximab through an IV on days 1, 8, and 15 of the first cycle, and day 1 of the second cycle. They also receive pembrolizumab through an IV on day 2 every 3 weeks for up to 2 years, and lenalidomide orally on days 1-14 every 3 weeks for up to 12 cycles, unless the disease worsens or side effects become too severe.

After finishing the treatment, patients will have follow-up visits 30 days later, every 3 months for the first year, and then every 6 months.

Eligibility Criteria

Inclusion Criteria

  • For Cohort 1: Must have follicular lymphoma that has returned after at least one previous treatment, including rituximab, and showed improvement for at least 6 months after the last rituximab treatment.
  • For Cohort 2: Must have follicular lymphoma or diffuse large B-cell lymphoma that has returned after at least two previous treatments, including CAR T cell therapy.
  • Must be willing to provide written consent to participate.
  • Must have measurable disease (tumors at least 1.5 cm in size).
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 120 days after the last dose.
  • Men must agree to use birth control during the study and for 120 days after the last dose.
  • Participants in Cohort 2 must be registered in the Revlimid REMS program and comply with its requirements.

Exclusion Criteria

  • Currently participating in another study or have used an investigational drug or device within 4 weeks before starting this study.
  • Have an immune deficiency or are using immunosuppressive therapy within 7 days before starting the study.
  • Have had a monoclonal antibody treatment within 4 weeks before starting the study and have not recovered from side effects.
  • Have had chemotherapy, targeted therapy, or radiation within 2 weeks before starting the study and have not recovered from side effects.
  • Have another active cancer that requires treatment, except for certain skin or cervical cancers.
  • Have active central nervous system lymphoma unless stable and not using steroids for at least 7 days before starting the study.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have lung disease or pneumonitis requiring steroids.
  • Have an active infection requiring treatment.
  • Have a condition or treatment that could interfere with the study.
  • Have psychiatric or substance abuse issues affecting participation.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have received certain immune therapies before.
  • Have HIV, active hepatitis B, or hepatitis C.
  • Have received a live vaccine within 30 days before starting the study.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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