A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

• Status: Recruiting
• Trial end date: 2029-04-03

Summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).

This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

• What side effects may happen from taking the study drug

• How much study drug is in your blood at different times

• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

• The impact from the study drug on your quality of life and ability to complete routine daily activities.

• Phase: Phase 3

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Doxorubicin; Prednisolone; Prednisone; Rituximab; Vincristine