Actively Recruiting
Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
70
Participants Needed
36
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) by expert review
- Patients with untreated NLPHL stage IB to IV or previously treated NLPHL at any stage
- Patients needing therapy due to symptoms, disease progression, or patient preference
- Measurable disease according to lymphoma response criteria
- Age 18 years or older
- ECOG performance status of 0 to 2 (Karnofsky score 60% or higher)
- Absolute neutrophil count of 1,000/mcL or higher
- Platelet count of 100,000/mcL or higher
- Total bilirubin within 1.5 times the normal limit (except Gilbert's syndrome)
- AST/ALT levels no more than 3 times the normal limit
- Glomerular filtration rate (GFR) of 40 mL/min or higher
- HIV patients on effective treatment with undetectable viral load within 6 months
- Patients with chronic hepatitis B must have undetectable viral load if on therapy
- Patients treated and cured for hepatitis C or with undetectable viral load if currently treated
- Patients with prior or concurrent cancer that does not interfere with study assessments
- Cardiac function assessed as New York Heart Association class 2B or better
- Agreement to use effective contraception during and after the study as required
- Ability and willingness to provide informed consent or have a legal representative consent
You will not qualify if you...
- Classical Hodgkin lymphoma or composite lymphoma
- Transformed NLPHL or suspicion of transformation needing cytotoxic therapy
- NLPHL relapse less than 6 months after rituximab-based therapy
- Unresolved side effects from prior cancer treatment above grade 1 except hair loss
- Currently receiving other investigational drugs
- Lymphoma involvement in the central nervous system
- History of allergic reactions to mosunetuzumab or rituximab
- Uncontrolled illness or conditions making participation unsafe
- Pregnant or breastfeeding women
- Prior allogeneic stem cell or solid organ transplant
- Receipt of live vaccines within 4 weeks before study drug or planned during study
- Use of other cancer therapies within 4 weeks before starting the study
- Significant cardiovascular, pulmonary, or central nervous system diseases affecting safety
- Recent severe infections or active infections at enrollment
- Use of systemic immunosuppressive medications within 2 weeks before study drug
- Known or suspected active Epstein-Barr virus or cytomegalovirus infection
- History of hemophagocytic lymphohistiocytosis (HLH)
AI-Screening
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Trial Site Locations
Total: 36 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
3
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
4
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States, 33065
Actively Recruiting
5
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States, 33166
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States, 33021
Actively Recruiting
8
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
9
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
11
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
12
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
13
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
14
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
15
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, United States, 64116
Actively Recruiting
16
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
17
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
18
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Suspended
19
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
20
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
21
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
22
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
23
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
24
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
25
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
26
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
27
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
28
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
29
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
30
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
31
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Active, Not Recruiting
32
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
33
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
34
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
35
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
36
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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