Peg-filgrastim Vs filgrastrim in pediatric patients. - Peg-filgrastim Vs filgrastrim in pediatric patients.

• Conditions: haematologic malignant tumors; MedDRA version: 6.1Level: PTClassification code 10000880

• Registration Number: EUCTR2007-001430-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI PADOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-0-17 years old
-transplant of autologue CSE
-mieloblast ablation with busulfan 16 mg/kg, melfalan 140-200mg/m2,etoposide 40-60mg/kg, cyclofosfamide 120-200 mg/kg,tiotepa 10-15 mg/kg;or radioterapy total body with 12-14.4 Gray.
- minimun dose of CD4
karnosky score > 90
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-NPT glutamina
-terapy with palefermin
- others sperimental treatments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Time necessary for recovery mieloid cells.;Secondary Objective: - days of fever<br>-number of infections<br>-days of mucositys<br>-days of <br>hospitalitation;Primary end point(s): Time necessary for recovery mieloid cells.