Titre |
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma |
Protocole ID |
EPCORE FL-1 |
ClinicalTrials.gov ID |
NCT05409066 |
Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
Phase |
Phase III |
Stade |
Lymphome folliculaire/zone marginale |
Type étude |
Clinique |
Médicament |
Epcoritamab en association avec rituximab et lénalidomide (R2) comparé à R2 |
Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
Ville |
Québec |
Investigateur(trice) principal(e) |
Dr Jean-François Larouche
|
Coordonnateur(trice) |
Philippe Nadeau
418-649-0252 poste 63115
|
Statut |
Actif en recrutement |
Date d'activation |
13-11-2023 |
Critètes d'éligibilité |
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
-
Participant has:
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
- >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
- Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ on a representative tumor biopsy based on the pathology report.
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
- Eligible to receive R2 per investigator determination
|
Critètes d'exclusion |
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization.
|