Phase II Study of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide for Patients with Relapsed B-cell Non-Hodgkin Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05615636

Provider View

This clinical trial is exploring whether a combination of four drugs—mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide—can help control B-cell Non-Hodgkin Lymphoma (NHL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if a combination of four drugs can safely and effectively treat patients with B-cell Non-Hodgkin Lymphoma (NHL) that has come back or not responded to earlier treatments. Researchers are looking at how well the treatment works, how long it lasts, and how it affects the immune system and the cancer environment.

Description

This study is testing a combination of four drugs—mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide—to see if they can help treat patients with B-cell Non-Hodgkin Lymphoma (NHL) that has returned or not responded to previous treatments. The main goals are to determine the safety of this drug combination and how well it works in shrinking the cancer. Researchers will also look at how long the treatment effects last and how it impacts the immune system and the cancer environment. Participants will receive the drug combination and undergo regular health checks to monitor their response and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed CD20+ Follicular Lymphoma (grade 1-3a) or relapsed CD20+ Diffuse Large B-cell Lymphoma.
  • Cancer has progressed or not responded after at least one previous treatment.
  • Able to provide written consent and follow the study protocol.
  • Aged 18 years or older.
  • Have at least one lymph node larger than 1.5 cm.
  • Adequate blood cell counts and organ function.
  • Willing to receive blood transfusions if needed.
  • Men must use contraception during and after treatment, and women must use two forms of contraception if of childbearing potential.
  • Women must have a negative pregnancy test before starting treatment.
  • Participants must be registered in the Revlimid REMS® program and comply with its requirements.
  • Able to take daily aspirin or other anticoagulation medication if needed.

Exclusion Criteria

  • Allergic to any study drug.
  • Previous treatment with polatuzumab vedotin, mosunetuzumab, tafasitamab, or lenalidomide.
  • Recent stem cell transplant or CAR-T therapy.
  • Eligible for stem cell transplant.
  • History of severe allergic reactions to antibody therapies.
  • Recent use of corticosteroids or other immunosuppressive medications.
  • Recent chemotherapy, immunotherapy, or radiotherapy.
  • History of another cancer within the last two years, except for certain skin or cervical cancers.
  • Serious medical conditions that could affect study participation.
  • History of autoimmune diseases, except for controlled hypothyroidism or Type 1 diabetes.
  • Active infections or recent major infections.
  • Known HIV, hepatitis B, or hepatitis C infection.
  • Recent vaccination with live vaccines.
  • Pregnant or breastfeeding women.
  • Known central nervous system involvement with lymphoma.
  • Recent major surgery or unhealed wounds.
  • History of stroke or bleeding disorders.
  • Participation in another clinical trial.

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