Study on Epcoritamab for Follicular Lymphoma Patients Not Achieving Complete Response with Initial Chemoimmunotherapy

Sponsor: Beth Israel Deaconess Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06510361

Provider View

This clinical trial is exploring the effectiveness of a new treatment, epcoritamab, for patients with follicular lymphoma who did not achieve a complete response after their first round of chemoimmunotherapy.

Patient Parameters

Program Overview

The purpose of this study is to test if epcoritamab, a type of antibody, can help treat follicular lymphoma in patients who did not fully respond to their initial treatment. Epcoritamab is designed to activate the immune system to target and destroy cancer cells. Although it is not yet approved by the FDA for follicular lymphoma, it is approved for other uses. Participants will undergo various tests and receive treatment over 12 cycles, with follow-up for two years. The study aims to include about 35 participants and is funded by Genmab, Inc.

Description

This study is a phase 2 trial focusing on patients with follicular lymphoma who did not achieve a complete response after their first treatment. Epcoritamab, the study drug, is a bispecific antibody that helps the immune system attack cancer cells. Participants will be screened for eligibility and will undergo various tests, including scans and blood tests, throughout the study. They will receive up to 12 cycles of treatment and will be monitored for two years. The study is open-label, meaning both the researchers and participants know what treatment is being given. Genmab, Inc. is providing the study drug for this research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with follicular lymphoma grade 1-3A that is CD20 positive.
  • Must have measurable disease with at least one lymph node of a certain size.
  • Initially diagnosed at stage III or IV.
  • Previously received at least one line of chemoimmunotherapy with specific drugs.
  • Achieved partial response or stable disease after initial treatment.
  • Completed prior treatment at least 4 weeks before starting epcoritamab.
  • Aged 18 years or older.
  • ECOG performance status of 0 to 2.
  • Life expectancy of more than 2 years.
  • Meet specific blood and organ function criteria.
  • If positive for hepatitis B or C, must have controlled viral load.
  • No evidence of other cancers for at least 2 years.
  • Willing to sign informed consent and follow study procedures.
  • Women of childbearing potential must use effective birth control during and after the study.
  • Men must use a barrier method of birth control during and after the study.

Exclusion Criteria

  • Use of experimental drugs in previous treatments.
  • Uncontrolled infections or heart conditions.
  • Uncontrolled neurological conditions.
  • Need for oxygen at rest.
  • Recent use of immunosuppressive therapy.
  • Known or suspected brain involvement by lymphoma.
  • Pregnant or breastfeeding women.
  • History of severe allergic reactions to similar drugs.
  • Recent vaccination with live vaccines.
  • Current alcohol or drug abuse, or unstable social situation.
  • Patients with HIV.

Locations

FACILITYZIPCITYSTATE
Beth Israel Deaconess Medical Center02215BostonMassachusetts

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