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Prophylaxis of Fungal Invasive Infections in Leukemia (PROFIL-C)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501098
First Posted: July 13, 2007
Last Update Posted: September 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northern Italy Leukemia Group
  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
Intervention Model: Single Group Assignment
Masking: None (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

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 12, 2007
First Posted: July 13, 2007
Last Update Posted: September 22, 2009
Last Verified: September 2009

Keywords provided by Northern Italy Leukemia Group:
Leukemia
Prophylaxis
Fungal Infections
Caspofungin

Additional relevant MeSH terms:
Leukemia
Infection
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Neoplasms by Histologic Type
Neoplasms
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Mycoses
Skin Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents


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