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

U

University of Cologne

Status and phase

Terminated
Phase 3

Conditions

Leukemia, Myelocytic, Acute

Treatments

Drug: voriconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00152594
NRA 150 0009

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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