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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004432-70-IT
Enrollment
Unknown
Registered
2006-11-10
Start date
2006-12-04
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

neutropenia MedDRA version: 6.1 Level: PT Classification code 10049085

Interventions

Trade Name: CANCIDAS*EV FL 50MG 10ML Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Caspofungin Concentration unit: mg milligram(s) Concentration type: equal C

Sponsors

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

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