Pegfilgrastim versus filgrastim after high-dose chemotherapy followed by autologous peripheral blood stem cell, in patients with hematologic and solid tumors a randomized phase II study - ND
- Conditions
- Patients with hematological neoplasia or solid tumors treated with high-dose chemotherapyMedDRA version: 6.1Level: HLGTClassification code 10027655
- Registration Number
- EUCTR2006-001409-27-IT
- Lead Sponsor
- ISTITUTO CLINICO HUMANITAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
Use concomitantly of experimental drugs Psicological, social condition which can hinder the study compliance Active infection at time of high-dose chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method