Spots Global Cancer Trial Database for Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

Official Title: Study of R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma (Age-adjusted Ipi >or= 2)

Study ID: NCT00169143

Conditions

Untreated CD20-positive Large B-cell Lymphoma

Interventions

Rituximab + ACVBP regimen plus Pegfilgrastim

Autologous stem cell transplant

Study Description

Brief Summary: Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).

Detailed Description: This is a phase II, multicentric, open-label, non-randomized study, evaluating the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI), and eligible for transplant. It is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a group sequential manner one planned interim analysis. The duration of the treatment period is approximately 26 weeks and patients are followed until Death. The total Duration of the study is expected to be 2.5 years.