OncRef

Clinical Trial: NCT05886036

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

Status:

RECRUITING

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-14

Study Overview

Brief Summary

This phase II trial compares mosunetuzumab to the usual treatment (rituximab) for improving survival in patients with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). Rituximab and mosunetuzumab are monoclonal antibodies. They bind 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 may be more effective at extending survival in patients with NLPHL than the usual approach with rituximab.

Official Title

NORM: Nodular Lymphocyte-Predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial With Either Rituximab or Mosunetuzumab

Conditions

Nodular Lymphocyte Predominant B-Cell Lymphoma, Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, Refractory Nodular Lymphocyte Predominant B-Cell Lymphoma

Intervention / Treatment

  • Procedure: Biopsy Procedure
  • Procedure: Biospecimen Collection
  • Procedure: Bone Marrow Biopsy
  • Procedure: Computed Tomography
  • Other: Fludeoxyglucose F-18
  • Biological: Mosunetuzumab
  • Procedure: Positron Emission Tomography
  • Biological: Rituximab
  • Biological: Rituximab and Hyaluronidase Human

Other Study ID Numbers

  • NCI-2023-04108
  • NCI-2023-04108
  • 10590
  • 10590
  • UM1CA186691

Start Date (Actual)

2024-01-23

Primary Completion Date (Estimated)

2028-10-31

Study Completion Date (Estimated)

2028-10-31

Enrollment (Estimated)

70

Study Type

Interventional

Phase

Phase 2