Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
Interventional
Phase 3
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2023
avril 2029
28 août 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Regional Universitaire de Tours - 37044 - Tours - Centre Val De Loire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) de Poitiers - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) Rennes - 35033 - Rennes - Bretagne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Angers - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Conception - 13005 - Marseille - Provence-Alpes-Cote d'Azur - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hopital Victor Dupouy Argenteuil - 95100 - Argenteuil - Ile De France - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie Strasbourg Europe (ICANS) - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Nantes University Hospital - 44093 - Nantes - Pays De La Loire - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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