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

This study has been terminated.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00152594
First received: September 7, 2005
Last updated: November 13, 2006
Last verified: November 2006
  Purpose

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 Intervention Phase
Leukemia, Myelocytic, Acute
Drug: voriconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

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

Estimated Enrollment: 150
Study Start Date: October 2004
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00152594

Locations
Germany
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
Investigators
Principal Investigator: Oliver A. Cornely, MD Klinikum der Universität Köln
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00152594     History of Changes
Other Study ID Numbers: NRA 150 0009
Study First Received: September 7, 2005
Last Updated: November 13, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014