NORM: Nodular Lymphocyte-Predominant Hodgkin Lymphoma Patients Treated in a Randomized Phase 2 Trial With Either Rituximab or Mosunetuzumab
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) of mosunetuzumab versus rituximab in NLPHL patients. SECONDARY OBJECTIVES: I. To compare the safety and antitumor activity of NLPHL patients treated with mosunetuzumab versus rituximab. II. To evaluate the molecular effects of mosunetuzumab and rituximab on tumor cells and the immune response and identify biomarkers of response or resistance with ribonucleic acid sequencing (RNAseq), whole exome sequencing (WES), immunohistochemistry (IHC) CD20, PD-1, PD-L1, PD-L2. III. To evaluate tumor microenvironment and peripheral i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 be capped at 40%. * 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 \[temperature \> 38 degrees Celsius (\> 100.4 degrees Fahrenheit)\], weight loss \[unexplained loss of \> 10 percent of b…
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
Locations (36)
- City of Hope Comprehensive Cancer CenterDuarte, California
- UM Sylvester Comprehensive Cancer Center at AventuraAventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Coral SpringsCoral Springs, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at DoralDoral, Florida