Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Brown University
Study ID
NCT04792502
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — DRUG
    Administered subcutaneously by injection beginning with 5 mg and increasing to 45 mg.
  • Lenalidomide — DRUG
    Patients in the augmentation cohort will be dosed continuously, 10 mg orally once daily, with or without food.

Study Details

BrUOG-401 is a prospective, single-arm, phase 2 trial of first-line therapy in adult patients with previously untreated FL or MZL. All patients will be assigned the same initial treatment plan, modified by interim response assessment (IRA) after Cycle 4. All patients will start treatment with four 21-day cycles (C1-4) of mosunetuzumab alone (using step-up dosing during C1), followed by IRA. Patients who achieve CR at IRA will continue with additional 4 cycles (C5-8) of mosunetuzumab. Patients who achieve PR at IRA will receive mosunetuzumab with lenalidomide augmentation during C5-8. Primary response assessment (PRA) will occur after C8. Patients who remain in PR at PRA will continue for additional 4 cycles (extended augmentation).

Key Dates

First listed
Mar 11, 2021
Start date
Jul 14, 2022
Status verified
Mar 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Planned Therapy

Primary Outcome Measure

Complete Response Rate [ Time Frame: At the end of Cycle 8 (each cycle is 21 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06511
BrUOG
[email protected]
401-863-3000
Scott Huntington, MD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
BrUOG
[email protected]
401-863-3000
Matthew Matasar, MD (PRINCIPAL_INVESTIGATOR)
Lifespan Cancer InsituteProvidenceRhode Island02903
BrUOG
[email protected]
401-863-3000
Adam J Olszewski, MD (PRINCIPAL_INVESTIGATOR)
Patrycja Dubielecka-Szczerba, PhD (SUB_INVESTIGATOR)

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