Comparison between single-dose peg-Filgrastim 100y/kg and G-CSF 5y/kg/day in the treatment of chemio-induced neutropenia and in mobilising circulating CD34+ hematopoietic cells in paediatric patients
DEC-NET Serial number IT502
Published online07/10/2005 12.31.00
Last updated09/11/2005 16.11.00
Other protocol ID number
Current trial statusOpen (actively recruiting new participants)
Major Disease
(ICD9 class)		AGRANULOCYTOSIS
Experimental drug
peg-FILGRASTIM
Control drug
FILGRASTIM
GenderBoth
Age (range)0-18 years

Eligibility criteria
Inclusion criteria
patients with solid tumors or non-leukaemic lynphoma with chemio-induced neutropenia (Karnofsky status >50)
Exclusion criteria
patients who have undergone hematopoietic stem cell trasplant, patients included in the European NBL-HROI Protocol, karnofky status < 50, and/or life expectancy of less than 4 weeks

Trial design/methodology
Phase3
Kind of studyEfficacy
DesignControlled
Randomised
Cross-over
Purpose of study
To evaluate the efficacy of single-dose peg-Filgrastim (100 y/Kg) compared to daily administration of G-CSF (5 y/Kg/die) per therapy cycle in chemio-induced neutropenia and in mobilising peripheral blood progenitor cells in paediatric patients with cancer.
Summary of study design, objectives, and ongoing research findings
Single-centre , randomised, prospective, phase III, study comparing single-dose peg-Filgrastim 100 y/kg and G-CSF 5y/kg/day in the treatment of chemio-induced neutropenia and in mobilising circulationg CD34+ hematopoietic progenitor cells in paediatric patients.
Principal investigator
NameDr. Sandro Dallorso
InstitutionIstituto Giannina Gaslini
Postal addressLargo G. Gaslini, 5
CityGenova
CountryITALY
Phone010 5636507
Fax
E-mailsandrodallorso@ospedale-gaslini.ge.it


Sponsor name
Istituto Giannina Gaslini (Ospedale)

ISRCTN  EudraCT