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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 31, 2026 → Oct 31, 2028
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Record History

The 50 most recent of 109 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 31, 2026 to Oct 31, 2028
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 3 of 37 sites
  2. Site details revised at 1 of 37 sitesv108
  3. Re-verified, no change to tracked fieldsv107
  4. Site details revised at 1 of 37 sitesv106
  5. Study sites revised (37)v105
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 36 to 37
    • Eligibility criteria expanded, about 24 words
    v104
  2. Site details revised at 1 of 36 sitesv103
  3. Site details revised at 1 of 36 sitesv102
  4. Study sites revised (36)v101
  5. Re-verified, no change to tracked fieldsv100
  6. Study sites: 35 to 36v99
  7. 38 versions Re-verified since Feb 14, 2026, no change to tracked fieldsv61-v98
  8. Study sites: 34 to 35v60
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05886036
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Nodular Lymphocyte Predominant B-Cell Lymphoma, Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, Refractory Nodular Lymphocyte Predominant B-Cell Lymphoma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov