Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Part of paid clinical trials in Miami, Florida.

Sponsor
Izidore Lossos, MD
Study ID
NCT06796998
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Marginal Zone Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Splenic Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Epcoritamab — BIOLOGICAL
    Epcoritamab will be administered via subcutaneous (SC) injection using a step-up dosing schedule as follows: * Cycle 1, Day 1: 0.16 mg * Cycle 1, Day 8: 0.8 mg * Cycle 1, Day 15: 3 mg * Cycle 1, Day 22: 48 mg * Cycles 2 to 3, Days 1, 8, 15 and 22: 48 mg * Cycles 4 to 9, Days 1 and 15: 48 mg * Cycles 10 to 12; Day 1: 48 mg

Study Details

The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).

Key Dates

Start date
Oct 13, 2025
Status verified
Oct 2025
Primary completion
Oct 15, 2028
Completion
Apr 15, 2031

Study Design

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

Arms

  • Experimental: Epcoritamab Group
    Participants will receive up to 12 cycles of Epcoritamab therapy, each cycle lasting 28 days. Total participation is up to 3 years.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Izidore Lossos, MD
[email protected]
305-243-4787
Izidore Lossos, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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