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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

Follicular Lymphoma (FL)

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). 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 the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* How the study drug affects quality of life and ability to complete routine daily activities.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient

NOTE: Other protocol defined inclusion/exclusion criteria apply

Lieu de l'étude

CHU de Quebec - Universite Laval
CHU de Quebec - Universite Laval
Quebec City, Quebec
Canada

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Cisss de la Monteregie-Centre
Cisss de la Monteregie-Centre
Greenfield Park, Quebec
Canada

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Ciusss de Lestrie Centre Hospitalier Universitaire de Sherbrooke
Ciusss de Lestrie Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Canada

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Saint John Regional Hospital
Saint John Regional Hospital
Saint John, New Brunswick
Canada

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Tom Baker Cancer Center
Tom Baker Cancer Center
Calgary, Alberta
Canada

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Étude parrainée par
Regeneron Pharmaceuticals
Participants recherchés
Plus d'informations
ID de l'étude: NCT06091254