Clinical trial · Interventional
Prophylaxis of Fungal Invasive Infections in Leukemia
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* To assess the overall clinical yield - in terms of efficacy and safety endpoints of adding caspofungin as prophylaxis of Invasive Pulmonary Aspergillosis in patients undergoing induction treatment for newly diagnosed acute leukemia * To investigate the prognostic significance of Ptx3 at diagnosis and during the first chemotherapy cycle with respect to the development of IPA
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Pulmonary Aspergillosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caspofungin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Patients will receive caspofungin, starting from the first day of induction chemotherapy for leukemia, as a single daily dose intravenously at the dosage of 70 mg q.d. and followed by 50 mg q.d. thereafter until documentation of complete hematologic remission after the first induction cycle or of leukemia persistence after one cycle of induction and one cycle of salvage chemotherapy. No stratification is planned.
- interventionNames
- Drug: Caspofungin
Primary outcomes (1)
- measure
- Occurrence of probable/proven invasive aspergillosis
Secondary outcomes (1)
- measure
- Death rate The rate of overall serious drug related AEs Variation in Ptx3 levels between patients, and in each patient at different times, and their correlation with the development of Invasive Pulmonary Aspergillosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Exclusion Criteria: * presence of signs or symptoms suspected of invasive fungal infection at enrollment * history of allergy, hypersensitivity, or any serious reaction to echinocandin * pregnancy or breast-feeding * acute hepatitis or moderate/severe hepatic insufficiency of any cause; * concomitant treatment with any systemic antifungal agent * recent prior use of caspofungin
References
Publications (1)
- DERIVEDCattaneo C, Monte S, Algarotti A, Audisio E, Borlenghi E, Campiotti L, Cerqui E, Fanizza C, Giuliani R, Mico C, Rocconi R, Salvi A, Salvi F, Verga L, Levis A, Lambertenghi Deliliers G, Pogliani EM, Tognoni G, Rambaldi A, Rossi G. A randomized comparison of caspofungin versus antifungal prophylaxis according to investigator policy in acute leukaemia patients undergoing induction chemotherapy (PROFIL-C study). J Antimicrob Chemother. 2011 Sep;66(9):2140-5. doi: 10.1093/jac/dkr271. Epub 2011 Jul 5. PMID 21729932