Clinical Trial: Study of Bortezomib Combined With ACVBP in Peripheral T-Cell Lymphoma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:

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).


Sponsor: Lymphoma Study Association

Current Primary Outcome: 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

Original Primary Outcome: : 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.

Current Secondary Outcome:

  • Efficacy
  • 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.


Original Secondary Outcome:

  • Efficacy:
  • • Response rate to treatment: complete response (CR + 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.


Information By: Lymphoma Study Association

Dates:
Date Received: August 26, 2005
Date Started: November 2005
Date Completion: November 2008
Last Updated: November 6, 2007
Last Verified: November 2007