Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
CD20-Positive Large B-Cell Lymphoma
Procedure: Autologous stem cell transplant
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).|
- - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
- - To compare response rate to induction treatments (ACVBP vs AC/ACE).
- - To evaluate response rate at the end of treatment.
- - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
- - To evaluate the safety and tolerability of Rituximab
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||August 2005|
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).
The final analysis was performed in June 2005.
|Hôpital Henri Mondor|
|Hôpital Saint Louis|
|Service d'Hématologie - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite cedex, France|
|Centre Henri Becquerel|
|CHRU de Nancy Brabois|
|Study Chair:||Corinne Haioun||Hôpital Henri Mondor, Créteil, France|