Prophylaxis of Fungal Invasive Infections in Leukemia

NCT00501098 | Completed Phase 2 DMC

• 1 other identifier: 2006-004432-70
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

• 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

Invasive Pulmonary Aspergillosis

Keywords

Leukemia; Prophylaxis; Fungal Infections; Caspofungin

Outcome Measures

Primary Outcomes (1)

• Occurrence of probable/proven invasive aspergillosis

Secondary Outcomes (1)

• 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.

Study Arms (1)

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EXPERIMENTAL

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

Interventions

Caspofungin DRUG

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.

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Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Italy Leukemia Group: lead

Study Sites (8)

Dipartimento di Ematologia e Medicina Trasfusionale - Azienda Osp. Nazionale Santi Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Location

USC Ematologia Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Location

Ematologia Centro TMO - Fondazione IRCSS Ospedale Maggiore

Milan, MI, Italy

Location

Ematologia - TMO - Ospedale San Gerardo

Monza, MI, Italy

Location

Ematologia 2 - Osp. Molinette San Giovanni Battista

Torino, TO, Italy

Location

Medicina Interna I Ospedale di Circolo

Varese, VA, 21100, Italy

Location

Divisione Ematologia Ospedale Umberto I

Mestre, VE, 30172, Italy

Location

Divisione Ematologia Spedali Civili, Azienda Ospedaliera, Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Related Publications (1)

• Cattaneo 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 DERIVED

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Leukemia; Mycoses

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Giuseppe Rossi, MD

  Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

• Chiara Cattaneo

  Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 13, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 22, 2009

Record last verified: 2009-09

Locations

IT (8)