A multicenter phase II study to evaluate the safety, tolerability and efficacy of caspofungin as prophylactic treatment of invasive fungal infections in patients with acute leukemia undergoing induction chemotherapy - ProFIL-C

Conditions: neutropenia
MedDRA version: 6.1Level: PTClassification code 10049085

Registration Number: EUCTR2006-004432-70-IT

Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- all patients with a diagnosis af acute leukemia who are enrolled in the clinical protocols of NILG for acute leukemia at diagnosis - age 18 - written informed consent
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- presence of clinical, radiological or microbiological evidence of invasive fungal infection at enrollment - concomitant use of systemic parenteral or oral antifungal agents - hypersensitivity, or any serious reaction to echinocandin - pregnancy or breast-feeding - acute hepatitis or moderate/severe hepatic insufficiency of any cause; - recent prior use of caspofungin - concomitant use of rifampin, carbamazepine, phenytoin, fenobarbital, or other inducers of CYP450 enzymes

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the overall clinical yield in terms of efficacy and safety endpoints of adding caspofungin as prophylaxis of IFI caused by Aspergillus spp. and Candida spp. in patients undergoing induction treatment for newly diagnosed acute leukemia;Secondary Objective: To investigate the prognostic significance of Ptx3 at diagnosis and during the first chemotherapy cycle with respect to the development of IPA;Primary end point(s): To assess the overall clinical yield in terms of efficacy and safety endpoints of adding caspofungin as prophylaxis of IFI caused by Aspergillus spp. and Candida spp. in patients undergoing induction treatment for newly diagnosed acute leukemia

Secondary Outcome Measures