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Recruiting Phase 2 NCT05389293

A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma

Trial Parameters

Condition Follicular Lymphoma
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 152
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-27
Completion 2026-12
Interventions
MosunetuzumabZanubrutinib

Brief Summary

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.

Eligibility Criteria

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 sites each with a diameter ≥ 3 cm * Presence of any of the following constitutional symptoms: * Fever (\>38C) of unclear etiology * Night sweats * Weight loss \>10% within the prior 6 months * Symptomatic splenomegaly * Mass-related symptoms * End-organ damage (e.g., elevated creatinine or elevated liver enzymes) that is clearly related to lymphomatous infiltration in the opinion of the investigato

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