NCT00306111

Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma

Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study

Detailed description

Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating cluster of differentiation 34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. Peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. After the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including total body irradiation-containing regimens).

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	pegfilgrastim	Single dose (6mg) one day after chemotherapy

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2011-12-01
• First posted: 2006-03-22
• Last updated: 2014-05-29

Locations

1 site across 1 country: Germany