Study on the Safety and Effectiveness of Mosunetuzumab and Polatuzumab Vedotin for B-Cell Non-Hodgkin Lymphoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40

ClinicalTrials ID:NCT03671018

This clinical trial is testing the safety and effectiveness of combining two drugs, Mosunetuzumab and Polatuzumab Vedotin, to treat different types of B-cell Non-Hodgkin Lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective the combination of Mosunetuzumab and Polatuzumab Vedotin is for treating patients with certain types of B-cell Non-Hodgkin Lymphoma. It will involve patients whose cancer has returned or not responded to previous treatments. The trial will start with finding the right dose and then expand to include more patients. It will also test a version of Mosunetuzumab that can be given under the skin, along with Polatuzumab Vedotin, for patients who have had at least two previous treatments for mantle cell lymphoma or diffuse large B-cell lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of follicular lymphoma, diffuse large B-cell lymphoma, or mantle cell lymphoma.
  • Have received at least one previous treatment that included anti-CD20 therapy for diffuse large B-cell lymphoma or follicular lymphoma.
  • For mantle cell lymphoma, have received at least two previous treatments, including anti-CD20 therapy, a BTK inhibitor, and either anthracycline or bendamustine.
  • Cancer must have returned after responding to previous treatments for at least 6 months, or not responded to previous treatments.
  • Have measurable cancer, with at least one tumor that can be measured by scans.
  • Have adequate blood, kidney, and liver function.

Exclusion Criteria

  • Have had previous treatment with Mosunetuzumab or similar drugs.
  • Have had previous treatment with Polatuzumab Vedotin.
  • Have more than mild nerve damage.
  • Have used any monoclonal antibody or similar treatments within 4 weeks before starting the study.
  • Have had chemotherapy or other cancer treatments within 4 weeks or 5 half-lives of the drug before starting the study.
  • Have had radiation therapy within 2 weeks before starting the study.
  • Have had a stem-cell transplant within 100 days before starting the study.
  • Have had CAR-T cell therapy within 30 days before starting the study.
  • Have had an allogeneic stem-cell transplant.
  • Have had a solid organ transplant.
  • Have a history of hemophagocytic lymphohistiocytosis (HLH).
  • Have a history of progressive multifocal leukoencephalopathy (PML).
  • Have or have had central nervous system lymphoma or disease.
  • Have a history of autoimmune disease.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham School of Medicine35249BirminghamAlabama
City of Hope91010DuarteCalifornia
University of Colorado Hospital - Anschutz Cancer Pavilion80045AuroraColorado
University of Miami Miller School of Medicine33136MiamiFlorida
Moffitt Cancer Center33612TampaFlorida
University of Michigan Hospital48109Ann ArborMichigan
Karmanos Cancer Institute48201DetroitMichigan
New York University Langone Medical Center10016New YorkNew York
Levine Cancer Institute28204CharlotteNorth Carolina
Penn State Milton S. Hershey Medical Center17033HersheyPennsylvania

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