Phase 2 Trial Comparing Mosunetuzumab and Rituximab Treatments for Nodular Lymphocyte-Predominant Hodgkin Lymphoma

What this Trial Is About

Researchers are comparing two immunotherapy agents, mosunetuzumab and rituximab, in patients with nodular lymphocyte-predominant Hodgkin lymphoma NLPHL. Both drugs target the CD20 protein on B cells and certain cancer cells to help the immune system attack cancer. This phase II trial aims to see which treatment better improves progression-free survival, along with evaluating safety, tumor response, and molecular effects on the immune system and tumor environment. Patients are randomly assigned to one of two treatment groups. One group receives mosunetuzumab under the skin on days 1, 8, and 15 of the first cycle and day 1 of following cycles every 21 days for up to 8 cycles, unless disease worsens or side effects occur. The other group receives rituximab through an IV on day 1 and rituximab with hyaluronidase under the skin on days 8, 15, and 22 every 28 days for up to 2 cycles, with adjustments if needed. Patients showing disease progression can switch to the other treatment after 12 weeks. Both groups undergo PETCT scans, bone marrow and tissue biopsies at baseline and possibly at the end of treatment, and blood sample collections throughout the study. Participants are involved in regular scans and biopsies to monitor their disease and response to treatment. Researchers measure progression-free survival up to 2 years, tumor response at weeks 12 and treatment end, overall survival, and molecular markers in tumor and blood samples. After completing treatment, patients are followed every six months for two years to track long-term outcomes and safety. The total study duration depends on individual treatment cycles and follow-up visits.

Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial