An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy
Memorial Sloan Kettering Cancer Center
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.
Description
After completing enrollment of the initial 53 subjects, the researchers plan to expand the study by an additional 23 subjects.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…