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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05389293
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab — DRUG
    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.
  • Zanubrutinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 27, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
152 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Agent Mosunetuzumab
    Participants with newly diagnosed FL in need of systemic therapy
  • Experimental: Mosunetuzumab + Zanubrutinib
    Participants with newly diagnosed FL in need of systemic therapy

Primary Outcome Measure

Rate of Complete Respons/CR [ Time Frame: Up to 1 year ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Georgetown University (Data Collection Only)Washington D.C.District of Columbia20007
Joseph Roswarski, MD
202-444-2223
Memorial Sloan Kettering at Basking Ridge Limited Protocol ActivitiesBasking RidgeNew Jersey07920
Lorenzo Falchi, MD
646-608-3705
Hackensack Meridian Health (Data collection only)HackensackNew Jersey07601
Lori Leslie, MD
551-996-3033
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Lorenzo Falchi, MD
646-608-3705
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Lorenzo Falchi, MD
646-608-3705
Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities)CommackNew York11725
Lorenzo Falchi, MD
646-608-3705
Memorial Sloan Kettering Westchester (Limited protocol activities)HarrisonNew York10604
Lorenzo Falchi, MD
646-608-3705
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Lorenzo Falchi, MD
[email protected]
646-608-3705
Memorial Sloan Kettering Nassau (Limited protocol activities)Rockville CentreNew York11553
Lorenzo Falchi, MD
646-608-3705

Find similar trials in Washington D.C., DC

By research site
Georgetown University (Data Collection Only)· Washington D.C., DCMemorial Sloan Kettering at Basking Ridge Limited Protocol Activities· Basking Ridge, NJHackensack Meridian Health (Data collection only)· Hackensack, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk- Commack (Limited protocol activities)· Commack, NY

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