NCT00169169

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

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).

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (planned)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CD20-Positive Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ACVBP
DRUG	ACE
DRUG	rituximab
PROCEDURE	Autologous stem cell transplant

Timeline

• Start date: 1999-10-01
• Completion: 2005-08-01
• First posted: 2005-09-15
• Last updated: 2005-09-15

Locations

5 sites across 1 country: France