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

Sponsor

University of Cologne (Other)

Overall Status

Terminated

CT.gov ID

NCT00152594

Collaborator

(none)

150

Enrollment

Locations

Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2004

Study Completion Date :

Jan 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Known proven, probable or possible invasive fungal infection at randomization or in patient history
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)
Any current fever unless explained by non-infectious causes
Antibacterial prophylaxis other than TMP/SMX
Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
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).

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)
Concomitant therapy with absorbable antifungals
Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
Known hypersensitivity or other contraindication to voriconazole
Patient is unwilling or unable to comply with the protocol.
Diseases or disabilities preventing the patient from participating in the trial
Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Johann Wolfgang Goethe-Universität Frankfurt am Main	Frankfurt am Main	Germany	60590
2	Universitätsklinikum Mannheim, Universität Heidelberg	Heidelberg	Germany	68305
3	Klinikum der Universität Köln	Köln	Germany	50931

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator: Oliver A. Cornely, MD, Klinikum der Universität Köln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00152594

Other Study ID Numbers:

NRA 150 0009

First Posted:

Sep 9, 2005

Last Update Posted:

Nov 14, 2006

Last Verified:

Nov 1, 2006

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Voriconazole

Study Results

No Results Posted as of Nov 14, 2006