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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Infection
Leukemia
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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014