Study on Odronextamab for Treating Low Tumor Volume Advanced Follicular Lymphoma

Sponsor: Gottfried von Keudell, MD PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07128641

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment called odronextamab for patients with advanced Follicular Lymphoma (FL) who have not received any prior treatment. Odronextamab is a type of immunotherapy that helps the immune system fight cancer.

Patient Parameters

Program Overview

The purpose of this study is to see if odronextamab, a new immunotherapy drug, is safe and effective for treating patients with advanced Follicular Lymphoma (FL) who have not been treated before. Odronextamab is a monoclonal antibody that helps the body's immune system target and destroy cancer cells. Participants will undergo various procedures, including blood tests, scans, and biopsies, to monitor their health and the treatment's effects. The study will last up to 126 days, with follow-up for up to 15 years. About 35 people are expected to participate in this study, which is supported by Regeneron Pharmaceuticals, Inc.

Description

This study is a phase 2 trial to evaluate the safety and effectiveness of odronextamab in patients with previously untreated Follicular Lymphoma (FL). Odronextamab is a type of immunotherapy that uses the body's immune system to fight cancer cells. Participants will be screened for eligibility and will have regular clinic visits, blood tests, and scans to monitor their health and the treatment's effects. The study drug, odronextamab, is not yet approved by the FDA for treating Follicular Lymphoma. Participants will receive the drug for up to 6 cycles, or 126 days, and will be followed for up to 15 years. The study is supported by Regeneron Pharmaceuticals, Inc., which provides the drug and funding for the research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Follicular Lymphoma (FL) that is CD20 positive.
  • Have a lymph node biopsy from the last 6 months.
  • Have at least one lymph node that is 1.5 cm or larger.
  • Be 18 years or older.
  • Have a performance status score greater than 2, indicating good overall health.
  • Have a life expectancy of more than 2 years.
  • Meet specific blood and organ function requirements, including:
    • Neutrophil count of at least 1000 cells/mcl.
    • Platelet count of at least 100,000 cells/mcl.
    • Hemoglobin level of at least 10 g/dL.
    • Adequate heart, liver, and kidney function as determined by specific tests.
  • Women of childbearing potential must use effective contraception during the study and for 6 months after the last dose.
  • Men must use birth control methods during the study and for 6 months after the last dose.
  • Ability to understand and sign a written informed consent document.

Exclusion Criteria

  • Have high tumor volume or need immediate treatment.
  • Have large tumors or multiple affected lymph nodes.
  • Have systemic symptoms like fever, night sweats, or weight loss for more than 2 weeks.
  • Have certain infections or uncontrolled medical conditions.
  • Have another active cancer within the past 2 years, except for certain skin or cervical cancers.
  • Have had prior treatment for lymphoma, including certain types of radiation.
  • Have uncontrolled heart or neurological conditions.
  • Are pregnant or unwilling to use effective contraception during and after the study.
  • Have a history of drug or alcohol abuse, or psychiatric illness that may affect study participation.
  • Have allergies to certain medications or vaccines.

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