Epcoritamab and Rituximab for First-line Follicular Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Reid Merryman, MD
Study ID
NCT05783609
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Epcoritamab — DRUG
    T-cell bispecific antibody, via subcutaneous injection
  • Rituximab — DRUG
    Chimeric anti-CD20 monoclonal antibody, via IV infusion

Study Details

The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: * Rituximab (a type of monoclonal antibody therapy) * Epcoritamab (a T-cell bispecific antibody)

Key Dates

Start date
Jun 21, 2023
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab + Rituximab
    Participants will undergo study procedures as outlined: * PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment. * Cycle 1: * Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab. * Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab. (Day 15 of Epcoritamab dosage will be administered in the hospital.) * Cycles 2 - 3: --Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab. * Cycles 4 - 9: * Day 1 of 4 week cycle: Predetermined dose of Epcoritamab. * Day 15 of 4 week cycle: Predetermined dose of Epcoritamab. * Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment. * Follow up visits for up to 5 years.
  • Experimental: Epcoritamab + Rituximab Expansion
    Participants will undergo study procedures as outlined: * PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment. * Cycle 1: * Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab. * Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab. * Cycles 2 - 3: --Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab. * Cycles 4 - 9: * Day 1 of 4 week cycle: Predetermined dose of Epcoritamab. * Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment. * Follow up visits for up to 5 years.

Primary Outcome Measure

End of Treatment (EOT) Complete Metabolic Response (CMR) Rate [ Time Frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Gottfried von Keudell, MD
[email protected]
Gottfried von Keudell, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Reid W Merryman, MD
[email protected]
617-632-6844
Reid W Merryman, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount Sinai HospitalNew YorkNew York10029
Joshua Brody, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642
Danielle Wallace, MD
[email protected]
The Ohio State University Wexner Medical CenterColumbusOhio43210
Yazeed Sawalha, MD
[email protected]
Medical College of WisconsinMilwaukeeWisconsin53226
Esta Konkol
[email protected]
414-805-4594
Sumana Devata, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAIcahn School of Medicine at Mount Sinai Hospital· New York, NYUniversity of Rochester Medical Center· Rochester, NYThe Ohio State University Wexner Medical Center· Columbus, OHMedical College of Wisconsin· Milwaukee, WI

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