Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
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).
Untreated CD20-Positive Large B-Cell Lymphoma
Drug: Rituximab + ACVBP regimen plus Pegfilgrastim
Procedure: Autologous stem cell transplant
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- To evaluate the optimal combined dose intensity of the drug regimen
- Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||January 2007|
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.
|Hôpital Henri Mondor|
|Service d'Hématologie Clinique - CHU Le Bocage|
|Hôpital Saint Louis|
|Service d'Hématologie - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite cedex, France|
|Centre Henri Becquerel|
|CHRU de Nancy Brabois|
|Study Chair:||Corinne Haioun, MD||Hôpital Henri Mondor, Créteil, France|