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

NCT00152594 | Terminated Phase 3

• 1 other identifier: NRA 150 0009
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Leukemia, Myelocytic, Acute

Outcome Measures

Primary Outcomes (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 Outcomes (11)

• 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

Interventions

voriconazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (3)

Klinikum der Universität Köln

Cologne, 50931, Germany

Location

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Mannheim, Universität Heidelberg

Heidelberg, 68305, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Oliver A. Cornely, MD

  Klinikum der Universität Köln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 2004
• Study Completion: January 1, 2006
• Last Updated: November 14, 2006

Record last verified: 2006-11

Locations

DE (3)