Study on Mosunetuzumab and Lenalidomide as First Treatment for Follicular and Marginal Zone Lymphoma

Sponsor: Brown University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04792502

Provider View

This clinical trial is testing a new treatment approach using mosunetuzumab, with or without lenalidomide, as the first therapy for adults with follicular or marginal zone lymphoma who have not received prior treatment.

Patient Parameters

Program Overview

The study, called BrUOG-401, is a phase 2 trial for adults with follicular or marginal zone lymphoma who have not been treated before. All participants will start with four cycles of mosunetuzumab alone. After these cycles, doctors will assess the response. If the cancer is completely gone, patients will continue with mosunetuzumab for four more cycles. If the cancer is partially reduced, lenalidomide will be added to the treatment for the next four cycles. The main evaluation will occur after eight cycles, and if the cancer is still partially reduced, treatment may continue with additional cycles.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and agree to the study requirements and sign a consent form.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of follicular or marginal zone lymphoma.
  • Must agree to provide a sample of lymphoma tissue if available.
  • Must have at least one measurable tumor.
  • Must not have received prior systemic therapy for lymphoma, except for certain steroids.
  • Must have a reason to start treatment for lymphoma.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have adequate blood cell counts and organ function.
  • Must agree to use effective birth control during and after the study due to potential risks to a developing fetus.
  • Must agree to comply with the lenalidomide safety program requirements.

Exclusion Criteria

  • Cannot have grade 3b follicular lymphoma or transformed lymphoma.
  • Cannot have had prior treatment with anti-CD20 antibodies or lenalidomide.
  • Cannot have had prior stem cell or organ transplants.
  • Cannot have severe allergies to certain antibodies or products.
  • Cannot have serious heart conditions or recent heart attacks.
  • Cannot have severe lung disease requiring certain treatments.
  • Cannot have certain autoimmune diseases, except for well-controlled conditions.
  • Cannot be using certain immunosuppressive medications recently.
  • Cannot have active infections or certain viral infections.
  • Cannot have received a live vaccine recently.
  • Cannot have certain neurological conditions, except for well-controlled cases.
  • Cannot have other cancers that could interfere with the study.
  • Cannot have significant liver disease or recent major infections.
  • Cannot have had major surgery recently, except for diagnostic purposes.
  • Cannot have abnormal lab results indicating liver or blood clotting issues.
  • Cannot have had recent radiation therapy.
  • Cannot be pregnant, breastfeeding, or in prison.

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