A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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]
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mosunetuzumab
DrugDuring 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.
Zanubrutinib
DrugIn 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.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Single Agent MosunetuzumabExperimental treatment 1 intervention
Group B: Mosunetuzumab + ZanubrutinibExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Up to 1 yearSecondary outcomes
1
Overall Response Rate/ORR
Assess the Overall Response Rate/ORR after treatment with single-agent SC mosunetuzumab mosunetuzumab
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov