A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-Cell Lymphoma
This is a multicentric, open-label, non-randomized, non-competitive clinical study,
evaluating the efficacy and safety of V-ACVBP chemotherapy in previously untreated patients
aged from 18 to 65 years with peripheral T-lymphoma.
It is anticipated that 60 subjects will be enrolled over two years (from June 2005 to May
The duration of the treatment period is approximately 28 weeks and patients are followed
The total duration of the study is expected to be 5 years (from June 2005 to May 2010).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy measured by event-free survival (EFS), events being defined as disease progression, institution of a new treatment for the lymphoma, relapse after complete response (CR), or death from any cause
Bertrand Coiffier, MD
Hospices Civils de Lyon, Lyon, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)