NCT00136565

Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Velcade	1.5 mg/m², D1, D5, 4 cycles
DRUG	Doxorubicin	75 mg/m², D1, 4 cycles
DRUG	Prednisone	60 mg/m², D1-D5, 4 cycles
DRUG	Cyclophosphamide	1200 mg/m², D1, 4 cycles
DRUG	Vindesine	2 mg/m², D1, D5, 4 cycles
DRUG	Bleomycin	10 mg, D1, D5, 4 cycles

Timeline

• Start date: 2006-01-08
• Primary completion: 2011-04-18
• Completion: 2011-04-18
• First posted: 2005-08-29
• Last updated: 2018-08-23

Locations

5 sites across 2 countries: Belgium, France