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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT and/or PET/CT scan
Mosunetuzumab
Biological/VaccineGiven SC
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT scan
Rituximab
Biological/VaccineGiven IV
Rituximab and Hyaluronidase Human
Biological/VaccineGiven SC
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Arm I (Rituximab, rituximab and hyaluronidase)Experimental treatment 5 interventions
Group B: Arm II (Mosunetuzumab)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
3-year milestone progression free survival (PFS)
Time frame
From date of registration to date of first observation of progressive disease, transformation to diffuse large B cell lymphoma, or death due to any cause, up to 3 years2
PFS
Time frame
From date of registration to date of first observation of progressive disease, transformation to diffuse large B cell lymphoma, or death due to any cause, up to 10 yearsSecondary outcomes
1
Overall survival
Will be estimated using the method of Kaplan-Meier and compared between treatment arms using cox regression model.
Time frame
Up to 10 years2
Overall response rate
Time frame
At week 403
Event free survival (EFS)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms using cox regression model.
Time frame
From date of registration to date of first occurrence of EFS event, up to 10 years4
Incidence of adverse events
Will be evaluated using the Common Terminology Criteria for Adverse Events version 5 items.
Time frame
Up to end of treatmentOther outcomes
1
PFS hazard ratios
Will be estimated for subgroups defined by sex, race and ethnicity with the corresponding 95% confidence intervals.
Time frame
Up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov