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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
1.5 mg/m², D1, D5, 4 cycles
75 mg/m², D1, 4 cycles
60 mg/m², D1-D5, 4 cycles
Groupe d'Etude des Lymphomes de l'Adulte
Yvoir, Belgium
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Centre Hospitalier Robert Debré
Reims, France
Centre Henri Becquerel
Rouen, France
Event-free survival (EFS)
percentage of patients alive with no event, events being defined as disease progression, institution of a new treatment for the lymphoma, relapse after complete response (CR), or death from any cause
Time frame: 2 years
Complete response rate unconfirmed (CR+CR uncertain)
percentage of patients with complete response
Time frame: 2 years
Partial response (PR) rate
percentage of patients with partial response
Time frame: 2 years
Progression free survival (PFS)
Duration of survival without progression
Time frame: 2 years
Duration of response in complete responders (CR + CRu)
Time frame: 2 years
Overall survival (OS)
Percentage of patients alive
Time frame: 2 years
Number of SAE
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1200 mg/m², D1, 4 cycles
2 mg/m², D1, D5, 4 cycles
10 mg, D1, D5, 4 cycles
Institut Gustave Roussy
Villejuif, France