An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
- The screening period = up to 4 weeks prior to the first administration of combined
- The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49
days after the last dose of treatment is planned for all patients.
- The follow-up period: Patients who are not progressing at the end of study treatment
will be followed until progression or initiation of another anti-lymphoma therapy. All
patients will be followed for two years to evaluate survival.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants achieving an Objective Response Rate
Clinical Sciences & Operations
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)