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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001430-14-IT
Enrollment
Unknown
Registered
2008-01-10
Start date
2007-02-19
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haematologic malignant tumors MedDRA version: 6.1 Level: PT Classification code 10000880

Interventions

Trade Name: NEULASTA Pharmaceutical Form: Solution for injection INN or Proposed INN: Pegfilgrastim Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .6- Trade Name:

Sponsors

AZIENDA OSPEDALIERA DI PADOVA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: -NPT glutamina -terapy with palefermin - others sperimental treatments

Design outcomes

Primary

MeasureTime frame
Main Objective: Time necessary for recovery mieloid cells.;Secondary Objective: - days of fever -number of infections -days of mucositys -days of hospitalitation;Primary end point(s): Time necessary for recovery mieloid cells.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026