Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00169143|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 8, 2006
|Condition or disease||Intervention/treatment||Phase|
|Untreated CD20-Positive Large B-Cell Lymphoma||Drug: Rituximab + ACVBP regimen plus Pegfilgrastim Procedure: Autologous stem cell transplant||Phase 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 until Death.
The total Duration of the study is expected to be 2.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2004|
|Estimated Study Completion Date :||January 2007|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169143
|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|