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

Sponsor: Lymphoma Study Association
Study ID: NCT00169169
Phase: PHASE3
Status: Terminated

Conditions

CD20-Positive Large B-Cell Lymphoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - 59 Years
Healthy Volunteers: Not accepted

Interventions

ACVBP — DRUG
ACE — DRUG
rituximab — DRUG
Autologous stem cell transplant — PROCEDURE

Study Details

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

Key Dates

Start date: Oct 31, 1999
Status verified: Sep 2005
Completion: Aug 31, 2005

Study Design

Enrollment: 430 participants
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Primary Outcome Measure

- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT