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RandPhIIIMosunetuzumabVsRituximabLowTumorBurdFollicularLymph

Cancer
Elizabeth A Brem
Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Non-Hodgkin's Lymphoma

Study Description

This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.

Eligibility

NOTE: This is NOT a comprehensive list of eligibility criteria. The list below describes key eligibility criteria for prospective study participants. A complete list of eligibility criteria will be available in the informed consent form.

Key inclusion criteria:

  1. Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach
  1. Participants must not have received allogeneic stem cell transplantation
  1. Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration
  1. Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory.

Key exclusion criteria:

  1. Participants who are pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped).
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