Study on the Safety and Effectiveness of Odronextamab Compared to Rituximab and Chemotherapy for Follicular Lymphoma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06091254

Provider View

This clinical trial is testing a new drug called odronextamab to see if it is safe and works well for people with follicular lymphoma, a type of non-Hodgkin lymphoma. The study will compare odronextamab to the standard treatment of rituximab and chemotherapy.

Patient Parameters

Program Overview

The study is investigating a new drug, odronextamab, for people with follicular lymphoma who have not been treated before. It has two parts: Part 1 will test the safety of odronextamab when used alone, and Part 2 will compare its effectiveness to rituximab and chemotherapy, which are the usual treatments for this condition. Researchers will also look at possible side effects, how the drug is processed in the body, if the body creates antibodies against it, and how it affects quality of life and daily activities.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CD20+ follicular lymphoma, Grade 1-3a, stage II bulky or stage III/IV.
  • Need treatment as specified in the study.
  • Have measurable disease shown by CT or MRI scans.
  • Have a performance status score of 0 to 2, meaning fully active or some restriction in physically strenuous activity but ambulatory.
  • Have adequate bone marrow and liver function.

Exclusion Criteria

  • Have lymphoma affecting the brain or spinal cord.
  • Have evidence of transformation to a more aggressive type of lymphoma.
  • Have other specific types of lymphoma or leukemia, such as Waldenström Macroglobulinemia or chronic lymphocytic leukemia.
  • Have received any previous systemic treatment for lymphoma.
  • Have infections or allergies to the study drug or its ingredients.

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