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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Hôpital Henri Mondor
Créteil, France
Service d'Hématologie Clinique - CHU Le Bocage
Dijon, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
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
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Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, France