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NCT05886036 · ClinicalTrials.gov registry record · Phase 2
Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial
A Phase 2 study of Nodular Lymphocyte Predominant B-Cell Lymphoma and Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT05886036: Recruiting Phase 2 study of Nodular Lymphocyte Predominant B-Cell Lymphoma and Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, sponsored by National Cancer Institute (NCI).
NCT05886036 is a Phase 2 study of Nodular Lymphocyte Predominant B-Cell Lymphoma and Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05886036, a Phase 2 study of Nodular Lymphocyte Predominant B-Cell Lymphoma and Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Will be assessed according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria classification. The overall PFS curve will be displayed by treatment arm using the Kaplan-Meier (KM) method, and statistical comparisons will be performed by a log-rank test.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- OTHER Fludeoxyglucose F-18
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Missouri
- University of Kansas Cancer Center - Briarcliff - Kansas City
- University of Kansas Cancer Center - North - Kansas City
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital - North Kansas City
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
California
- City of Hope Comprehensive Cancer Center - Duarte
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT05886036 shows while recruiting
NCT05886036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 3 conditions, with Nodular Lymphocyte Predominant B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05886036 names 20 study sites across 6 states, led by Florida, Missouri, Kansas.
Frequently Asked Questions
What is clinical trial NCT05886036 about?
NCT05886036 is a clinical study titled "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 ...
What is the current status of trial NCT05886036?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-01-23. Estimated completion is 2026-10-31.
What conditions does trial NCT05886036 study?
This clinical trial studies the following conditions: Nodular Lymphocyte Predominant B-Cell Lymphoma, Recurrent Nodular Lymphocyte Predominant B-Cell Lymphoma, Refractory Nodular Lymphocyte Predominant B-Cell Lymphoma.
What interventions are being tested in trial NCT05886036?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT05886036?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05886036 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05886036's enrollment target sits among peer trials
70 937th of 2000 higher than 1,037 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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