Status:
COMPLETED
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
Lead Sponsor:
Armando Santoro, MD
Conditions:
Hematological Neoplasms
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
- Adequate organ function
- Written informed consent.
Exclusion
- Use of other experimental drugs
- Active infection
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00410696
Start Date
September 1 2006
End Date
November 1 2008
Last Update
July 1 2013
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089