RecruitingPhase 2NCT05886036

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

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

Sponsor

National Cancer Institute (NCI)

Enrollment

70 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two immunotherapy drugs — rituximab (the current standard) and mosunetuzumab (a newer option) — for treating nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL), a rare and slow-growing type of lymphoma. **You may be eligible if...** - You have been confirmed by biopsy to have NLPHL - You have not previously been treated (for certain stages), or your NLPHL has come back after prior treatment - Your doctor has determined that you need treatment now (not just monitoring) due to symptoms or disease progression - Your cancer is measurable on imaging scans **You may NOT be eligible if...** - You have a different type of lymphoma that was misdiagnosed as NLPHL - You have had certain types of prior treatments that would conflict with the study drugs - You have active serious infections or significant organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tissue biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo PET/CT

OTHERFludeoxyglucose F-18

Receive FDG

BIOLOGICALMosunetuzumab

Given SC

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALRituximab

Given IV

BIOLOGICALRituximab and Hyaluronidase Human

Given SC

Locations(35)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05886036