Patients with hematological neoplasia or solid tumors treated with high-dose chemotherapy MedDRA version: 6.1 Level: HLGT Classification code 10027655
Conditions
Interventions
Product Name: filgrastim
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Filgrastim
CAS Number: 121181-53-1
Concentration unit: µg microgram(s)
Concentration type: equ
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 61619; 18 years Normal cardiac, hepatic renal and lung function Patients with hematological neoplasia or solid tumor treated with High-dose chemotherapy with autologous peripheral stem cell reinfusion The CD34 number must be at least 3 x106/kg Written consent signed by the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use concomitantly of experimental drugs Psicological, social condition which can hinder the study compliance Active infection at time of high-dose chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of pegfilgrastim compared to filgrastim;Secondary Objective: Evaluation of immunological reconstitution after peg filgrastim and filgrastim;Primary end point(s): To demonstrate the non-inferiority of pegfilgrastim compared to filgrastim | — |
Countries
Italy
Outcome results
None listed