Study on Odronextamab and Chemotherapy vs. Rituximab and Chemotherapy for Adults with Follicular Lymphoma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06097364

Provider View

This clinical trial is testing a new drug, odronextamab, combined with chemotherapy to see if it is safe and effective for treating adults with follicular lymphoma, compared to the current standard treatment using rituximab and chemotherapy.

Patient Parameters

Program Overview

This study is exploring a new treatment option for adults with follicular lymphoma, a type of non-Hodgkin lymphoma. The trial involves a new drug called odronextamab, which is being tested in combination with chemotherapy. The study is divided into three parts. In the first part, researchers will determine the safest dose and schedule for odronextamab with chemotherapy. In the second part, they will compare this new combination to the standard treatment of rituximab with chemotherapy to see which works better. The study will also look at potential side effects, how the drug is processed in the body, and its impact on patients' quality of life.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CD20+ follicular lymphoma, grade 1-3a, stage II bulky or stage III/IV.
    • For Part 1A: Previously untreated or relapsed/refractory follicular lymphoma with a FLIPI-1 score of 3 to 5.
    • For Part 1B: Previously untreated follicular lymphoma with a FLIPI-1 score of 3 to 5.
    • For Part 2: Previously untreated follicular lymphoma with a FLIPI-1 score of 0 to 5.
  • Have measurable disease as shown by CT or MRI scans.
  • Have an ECOG performance status of 0 to 2, indicating good overall health.
  • Have adequate bone marrow and liver function.

Exclusion Criteria

  • Have lymphoma affecting the brain or spinal cord.
  • Have evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
  • Have Waldenström macroglobulinemia, grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma.
  • Have had recent major surgery or a history of organ transplantation.
  • Have another type of cancer unless it has been fully treated, or have any other significant active disease or medical condition that could interfere with the study or pose a risk to the participant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.