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).
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
Hôpital Henri Mondor, Créteil, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)