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

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.

Trial Details

NCT ID
NCT05886036
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Bone Marrow Biopsy
  • Computed Tomography
  • Fludeoxyglucose F-18
  • Mosunetuzumab
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Aventura, Florida, United States|25.95648,-80.13921
  • Coral Gables, Florida, United States|25.72149,-80.26838
  • Coral Springs, Florida, United States|26.27119,-80.2706
  • Deerfield Beach, Florida, United States|26.31841,-80.09977

Key Eligibility Criteria

  • Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review.
  • Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will…
  • Previously treated NLPHL, any stage.
  • According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever \[tempe…

For full eligibility, visit ClinicalTrials.gov.

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