Study of Bortezomib Combined With ACVBP in Peripheral T-Cell Lymphoma
Recruitment status was Active, not recruiting
The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP [doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone]) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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
- Response rate to treatment: complete response (CR + complete response unconfirmed [CRu]) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
- Progression free survival (PFS)
- Duration of response in complete responders (CR + CRu)
- Overall survival (OS)
- Safety: safety evaluations will be based on collection of adverse events (AEs), physical examination findings and clinical laboratory results.
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||November 2008|
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 2007).
The duration of the treatment period is approximately 28 weeks and patients are followed until death.
The total duration of the study is expected to be 5 years (from June 2005 to May 2010).
|Groupe d'Etude des Lymphomes de l'Adulte|
|Service d'Hématologie - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite cedex, France, 69495|
|Centre Hospitalier Robert Debré|
|Reims, France, 51092|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Institut Gustave Roussy|
|Study Chair:||Bertrand Coiffier, MD||Hospices Civils de Lyon, Lyon, France|
|Principal Investigator:||Alain Delmer, MD||Centre Hospitalier Robert Debré|