Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)
About this trial
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds 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 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.
Eligibility criteria
Qualifiers
Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory.
NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not required. Molecular testing is not required.
Participants must not have follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B)
Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
Disqualifiers
None
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Computed Tomography
- Mosunetuzumab
- Positron Emission Tomography
- Rituximab
- Rituximab and Hyaluronidase Human
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov