Prophylaxis of Fungal Invasive Infections in Leukemia (PROFIL-C)
This study has been completed.
Sponsor:
Northern Italy Leukemia Group
Information provided by:
Northern Italy Leukemia Group
ClinicalTrials.gov Identifier:
NCT00501098
First received: July 12, 2007
Last updated: September 21, 2009
Last verified: September 2009
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Purpose
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Invasive Pulmonary Aspergillosis |
Drug: Caspofungin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Northern Italy Leukemia Group:
Primary Outcome Measures:
- Occurrence of probable/proven invasive aspergillosis [ Time Frame: _ ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: _ ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
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. |
Drug: Caspofungin
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. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501098
Locations
| Italy | |
| Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo | |
| Alessandria, AL, Italy | |
| USC Ematologia Ospedali Riuniti di Bergamo | |
| Bergamo, BG, Italy | |
| Ematologia Centro TMO - Fondazione IRCSS Ospedale Maggiore | |
| Milano, MI, Italy | |
| Ematologia - TMO - Ospedale San Gerardo | |
| Monza, MI, Italy | |
| Ematologia 2 - Osp. Molinette San Giovanni Battista | |
| Torino, TO, Italy | |
| Medicina Interna I Ospedale di Circolo | |
| Varese, VA, Italy, 21100 | |
| Divisione Ematologia Ospedale Umberto I | |
| Mestre, VE, Italy, 30172 | |
| Divisione Ematologia Spedali Civili, Azienda Ospedaliera, Spedali Civili di Brescia | |
| Brescia, Italy, 25123 | |
Sponsors and Collaborators
Northern Italy Leukemia Group
Investigators
| Principal Investigator: | Giuseppe Rossi, MD | Spedali Civili di Brescia |
| Principal Investigator: | Chiara Cattaneo | Spedali Civili di Brescia |
More Information
No publications provided by Northern Italy Leukemia Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Giuseppe Rossi, Spedali Civili di Brescia |
| ClinicalTrials.gov Identifier: | NCT00501098 History of Changes |
| Other Study ID Numbers: | 2006-004432-70 |
| Study First Received: | July 12, 2007 |
| Last Updated: | September 21, 2009 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Northern Italy Leukemia Group:
|
Leukemia Prophylaxis Fungal Infections Caspofungin |
Additional relevant MeSH terms:
|
Aspergillosis Leukemia Mycoses Invasive Pulmonary Aspergillosis Pulmonary Aspergillosis Neoplasms by Histologic Type Neoplasms Lung Diseases, Fungal |
Lung Diseases Respiratory Tract Diseases Caspofungin Echinocandins Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013