Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma. A Phase II Multicenter Study "BENTLY"
The primary objective of this study is to define the activity of Bendamustine for the
treatment of T cells lymphomas. The activity of Bendamustine is determined by the response
rate (RR) to the treatment within 22 days after intravenous infusion which enables to get a
confidence interval of 95 % for the probability of an overall response rate (ORR).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the overall response rate (ORR) (CR+CRu+PR)
36 months follow-up
Gandhi DAMAJ, MD MS
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)