Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

Part of paid clinical trials in Stanford, California.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06510361
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Epcoritamab — DRUG
    Humanized IgG1 bispecific antibody, 5 or 60 mL vial, via subcutaneous (under the skin) injection per protocol.

Study Details

This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment. The name of the study drug in this research study is: -Epcoritamab (a type of antibody)

Key Dates

Start date
Nov 20, 2024
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
May 1, 2028

Study Design

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

Arms

  • Experimental: Epcoritamab
    35 participants will be enrolled and will complete study procedures as follows: * Baseline visit with imaging (CT, MRI or PET scan) and bone marrow biopsy. * Imaging after Cycles 3 and 6 only. * Cycles 1-3: --Days 1, 8, 15 and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily * Cycles 4-9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily * Cycles 10-12: --Day 1 of 28 day cycles: Predetermined dose of Epcoritamab 1x daily * End of Treatment visit with imaging and bone marrow biopsy. * Follow up: every 3 months for 2 years or until disease worsens. * Off study visit with imaging.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: CRR expected to be observed up to 12 months. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
StanfordStanfordCalifornia94305
Joseph Schroers-Martin, MD
[email protected]
Joseph Schroers-Martin, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Gottfried von Keudell, MPH, PhD
[email protected]
Dea Hunsickder, PhD
[email protected]
Gottfried von Keudell, MD PhD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Joshua Brody, MD
[email protected]
Joshua Brody, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford· Stanford, CABeth Israel Deaconess Medical Center· Boston, MAIcahn School of Medicine at Mount Sinai· New York, NY

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