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 Adult Participants With Previously Untreated Follicular Lymphoma

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 when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL).

Trial Details

NCT ID

NCT06091254

Phase

PHASE3

Sponsor

Regeneron Pharmaceuticals

Status

RECRUITING

Cancer Type

Non-Hodgkin Lymphoma Lymphoma

Interventions

Odronextamab
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone/prednisolone

Locations (sample)

Tucson, Arizona, United States|32.22174,-110.92648
Los Angeles, California, United States|34.05223,-118.24368
Orange, California, United States|33.78779,-117.85311
Noblesville, Indiana, United States|40.04559,-86.0086
Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
Need for treatment as described in the protocol
Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

For full eligibility, visit ClinicalTrials.gov.

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