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Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia

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. Identifier: NCT00152594
Recruitment Status : Terminated
First Posted : September 9, 2005
Last Update Posted : November 14, 2006
Information provided by:
University of Cologne

Brief Summary:

The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML).

Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.

Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Drug: voriconazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase III Study of Safety, Tolerance, Efficacy, Pharmacokinetics, and Costs of Therapy With Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia
Study Start Date : October 2004
Study Completion Date : January 2006

Primary Outcome Measures :
  1. To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo

Secondary Outcome Measures :
  1. To determine and compare between study arms the: incidence of fever and other signs of infection
  2. incidence and type of documented bacteremia
  3. rate of patients with systemic open-label antifungal therapy
  4. time to initiation of systemic open-label antifungal therapy
  5. duration of absolute neutrophil count < 500/µl
  6. rate and type of proven, probable and possible breakthrough invasive fungal infections
  7. rate of patients with fever of unknown origin
  8. incidence and severity of adverse events
  9. trough voriconazole plasma level after day 8 of study treatment
  10. direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
  11. overall costs in terms of the diagnosis related groups applied to the study patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Newly diagnosed or relapsed, de novo or secondary AML
  2. First induction chemotherapy cycle
  3. Expected neutropenic phase of a minimum duration of 10 days
  4. Age >= 18 years
  5. Legally signed consent form

Exclusion Criteria:

  1. Known proven, probable or possible invasive fungal infection at randomization or in patient history
  2. Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
  3. Any current fever unless explained by non-infectious causes
  4. Antibacterial prophylaxis other than TMP/SMX
  5. Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
  6. Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:

    • Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine);
    • Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulfonylureas, ergot alkaloids, sirolimus, vinca alkaloids).
  7. Subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
  8. Concomitant therapy with absorbable antifungals
  9. Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
  10. Known hypersensitivity or other contraindication to voriconazole
  11. Patient is unwilling or unable to comply with the protocol.
  12. Diseases or disabilities preventing the patient from participating in the trial
  13. Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug

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 identifier (NCT number): NCT00152594

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Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Germany, 60590
Universitätsklinikum Mannheim, Universität Heidelberg
Heidelberg, Germany, 68305
Klinikum der Universität Köln
Köln, Germany, 50931
Sponsors and Collaborators
University of Cologne
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Principal Investigator: Oliver A. Cornely, MD Klinikum der Universität Köln
Layout table for additonal information Identifier: NCT00152594    
Other Study ID Numbers: NRA 150 0009
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: November 2006
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors