NCT00169143

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 61 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Untreated CD20-positive Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab + ACVBP regimen plus Pegfilgrastim
PROCEDURE	Autologous stem cell transplant

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-15
• Last updated: 2018-08-23

Locations

6 sites across 1 country: France