Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Izidore Lossos, MD
Study ID
NCT06569680
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extranodal Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — DRUG
    Mosunetuzumab will be administered via subcutaneous (SC) injection using a step-up dosing model. Participants will receive Mosunetuzumab on days 1, 8, and 15 of Cycle 1, and on day 1 of Cycles 2 through 8 as follows: * Cycle 1 Day 1: 5mg * Cycle 1 Day 8: 45mg * Cycle 1 Day 15: 45mg * Cycles 2 through 8, Day 1: 45mg

Study Details

The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. This study will help doctors understand if Mosunetuzumab improves outcomes in people with EMZL and if it is safe to use.

Key Dates

Start date
Nov 19, 2024
Status verified
Oct 2025
Primary completion
Dec 1, 2030
Completion
Dec 1, 2030

Study Design

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

Arms

  • Experimental: Mosunetuzumab Treatment Group
    Participants in this group will receive Mosunetuzumab for eight (8) 21-day cycles. Total participation is about 3.5 years.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Izidore Lossos, MD
[email protected]
Izidore Lossos, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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