Status:
TERMINATED
Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia
Lead Sponsor:
University of Cologne
Conditions:
Leukemia, Myelocytic, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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: Voriconaz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00152594
Start Date
October 1 2004
End Date
January 1 2006
Last Update
November 14 2006
Active Locations (3)
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1
Klinikum der Universität Köln
Cologne, Germany, 50931
2
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Germany, 60590
3
Universitätsklinikum Mannheim, Universität Heidelberg
Heidelberg, Germany, 68305