Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
- 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
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Vandœuvre-lès-Nancy, France