A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
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
1 other identifier
interventional
152
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2022
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 19, 2026
May 1, 2026
4.5 years
May 23, 2022
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Complete Respons/CR
The primary objective of the study is to determine the rate of Complete Response/CR to single-agent SC mosunetuzumab according to the 2014 Lugano response criteria in participants with newly diagnosed Follicular Lymphoma in need of systemic therapy.
Up to 1 year
Secondary Outcomes (1)
Overall Response Rate/ORR
Up to 3 years
Study Arms (2)
Single Agent Mosunetuzumab
EXPERIMENTALParticipants with newly diagnosed FL in need of systemic therapy
Mosunetuzumab + Zanubrutinib
EXPERIMENTALParticipants with newly diagnosed FL in need of systemic therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- +28 more criteria
You may not qualify if:
- Inability to comply with all the study-related procedures, in the investigator's judgement.
- FL grade 3B or transformed FL
- Patients not meeting criteria for systemic therapy as outlined in section 6.1 and Appendix 4
- Patients unfit for chemoimmunotherapy for reasons including, but not limited to, advanced age and medical comorbidities
- FL presenting with isolated extra-nodal localizations, such as duodenal FL, cutaneous FL or FL of the testis
- Pediatric FL
- Prior anti-lymphoma therapy
- Prior solid organ transplantation
- Prior allogeneic stem cell transplantation within 5 years of FL diagnosis. Previously transplanted patients must be off all GVHD-related prophylaxis in order to be considered eligible.
- Current or prior central nervous system (CNS) lymphoma
- Current or past history of significant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed
- Patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed
- Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease \[see Appendix 6\], myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
- Significant active pulmonary disease (e.g., bronchospasm or obstructive pulmonary disease)
- +48 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Georgetown University (Data Collection Only)
Washington D.C., District of Columbia, 20007, United States
Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities
Basking Ridge, New Jersey, 07920, United States
Hackensack Meridian Health (Data collection only)
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Falchi, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
May 25, 2022
Study Start
May 27, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.