Spots Global Cancer Trial Database for Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

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Trial Identification

Brief Title: Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

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).

Study ID: NCT00169169

Conditions

CD20-Positive Large B-Cell Lymphoma

Interventions

ACVBP

ACE

rituximab

Autologous stem cell transplant

Study Description

Brief Summary: Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.

Detailed Description: 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.