Informations générales (source: ClinicalTrials.gov)
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2) (OLYMPIA-2)
Interventional
Phase 3
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
novembre 2023
juillet 2029
28 juin 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.
Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with
follicular lymphoma that has come back after treatment (called "relapsed") or did not
respond to treatment (called "refractory") are eligible to take part only in Part 1A of
the study.
This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2
(randomized - controlled).
The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study
drug in combination with chemotherapy is and to determine the dose and schedule of the
study drug to be combined with chemotherapy to be used in Part 2 of the study.
The aim of Part 2 of the study is to assess how effective the combination of the study
drug with chemotherapy is in comparison with the combination of 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 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)
- The impact from the study drug on 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 | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | 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 | |||||
| Cannes Hospital (Centre Hospitalier Cannes Simone Veil) - 06400 - Cannes - Alpes Maritimes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens) - 62300 - Lens - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Mont-de-Marsan - 40024 - Mont de Marsan - Nouvelle Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Saint Nazaire - 44600 - Saint Nazaire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Emile Roux - 43012 - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque - 33600 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Grenoble - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHRU de Tours - 37044 - Tours - Centre Val De Loire - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint-Etienne - 42055 - Saint-Etienne - 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 du Gard - 30029 - Nimes - Gard - France | Contact (sur clinicalTrials) | ||||
| Nantes University Hospital - 44093 - Nantes - Pays De La Loire - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a,
stage II bulky or stage III / IV
1. For Part 1A: previously untreated participants who have Follicular Lymphoma
International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed
tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the
protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow and hepatic function.
Key
1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a,
stage II bulky or stage III / IV
1. For Part 1A: previously untreated participants who have Follicular Lymphoma
International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed
tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the
protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow and hepatic function.
Key
1. Participants with central nervous system lymphoma or leptomeningeal lymphoma
2. Participants with histological evidence of transformation to a high-grade or diffuse
large B-cell lymphoma
3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma),
grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic
lymphoma
4. Recent major surgery and history or organ transplantation
5. A malignancy other than NHL unless the participant is adequately and definitively
treated and any other significant active disease or medical condition that could
interfere with the conduct of the study or put the participant at significant risk,
as described in the protocol.
Note: Other protocol-defined Inclusion/Exclusion criteria apply