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)
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
The total Duration of the study is expected to be 2.5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the optimal combined dose intensity of the drug regimen
Corinne Haioun, MD
Hôpital Henri Mondor, Créteil, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)