At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed classic follicular lymphoma (cFL)
- ✓Follicular lymphoma with uncommon features (uFL) including diffuse growth pattern eligible
- ✓Low-tumor burden disease: nodal/extra-nodal masses <7 cm, ≤3 sites >3 cm, no B symptoms, no symptomatic splenomegaly, no compression syndrome, no pleural/peritoneal effusion
- ✓Ann Arbor stage II, III, or IV; stage I allowed if ineligible for/declining radiation
- ✕Follicular lymphoma with blastoid or large centrocyte cytological features
- ✕Follicular large B-cell lymphoma (FLBL, previously grade 3B)
- ✕Prior systemic therapy for follicular lymphoma (radiation for early-stage disease allowed)
- ✕Active or uncontrolled infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
In Brief
A Phase 3 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 4 other interventions for Classic Follicular Lymphoma and Follicular Lymphoma With Unusual Cytological Features. Currently recruiting, targeting 600 participants across 268 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Patients receive rituximab IV on day 1 of cycle 1 and receive rituximab and hyaluronidase SC on days 8, 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles. Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up.
Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up.
Interventions
Undergo blood sample collection
Undergo CT and/or PET/CT scan
Given SC
Undergo PET/CT scan
Given IV
Given SC