Memorial Sloan Kettering Cancer Center
The purpose of this study is to find out if mosunetuzumab is an effective treatment in people with follicular lymphoma that was recently diagnosed and have not yet received any treatments for their disease.
After completing enrollment of the initial 53 subjects, the researchers plan to expand the study by an additional 23 subjects.
Inclusion Criteria: * Signed Informed Consent Form(s) * Ability to comply with all the study-related procedures, in the investigator's judgement * Age 18 years or older * ECOG performance Status of 0, 1, or 2 \[Appendix 2\] * Untreated histologically documented FL of grade 1, 2, or 3A * Stage II bulky (noncontiguous), III, or IV bulky or high burden disease \[Appendix 3\] * Need of systemic therapy as evidenced by at least one of the following criteria \[also see Appendix 4\]: * Bulky disease defined as: * Nodal or extranodal mass \> 7cm in maximum diameter * ≥ 3 nodal or extranodal…
During Cycle 1, Mosunetuzumab will be administered SC in a step-up dosing schedule at the dose of 5 mg on Day 1, 45 mg on Day 8, and 45 mg on Day 15). Beginning with Cycle 2, Mosunetuzumab will be administered SC at the dose of 45 mg on Day 1. Each Cycle lasts 3 weeks. After the first 8 cycles (approximately 6 months) of therapy, subjects who achieved CR will discontinue therapy, those who attained a PR will receive up to 17 doses (approximately 12 months). Subjects who achieve stable disease (SD) or who experience progressive disease (PD) will be taken off study and subsequent management will be left at the discretion of the investigator.
In Cohort 2, Zanubrutinib is concurrently administered continuously starting on Cycle 1, Day -7 and is given for 12 months in both patients with CR and those with PR. Cohort 2 patients with evidence of circulating lymphoma cells at baseline will initiate Zanubrutinib dosing on Cycle 2 Day 1 and continue dosing for 12 months.