NCT00410696

Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Armando Santoro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

Detailed description

Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

Conditions

• Hematological Neoplasms
• Tumors

Interventions

Type	Name	Description
DRUG	Filgrastim	5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
DRUG	Pegfilgrastim	6 mg/day sc at day +1

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2006-12-13
• Last updated: 2013-07-01

Locations

1 site across 1 country: Italy