Acute Myelogenous Leukaemia (AML) Cancer Leukaemia
Conditions
Interventions
Voriconazole 200 mg twice a day (bid) orally (po) or placebo
This trial was prematurely terminated on 19 January 2006 due to establishment of a new standard treatment, which made the placebo group of
Sponsors
University Hospital of Cologne (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: Patients with first induction chemotherapy for acute myelogenous leukaemia (AML): 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 greater than 18 years 5. Legally signed informed consent
Exclusion criteria
Exclusion criteria: 1. Known proven, probable or possible invasive fungal infection at randomization or in patient history 2. CT with any signs of a fungal infection according to the EORTC/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. 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: 6.1. Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine) 6.2. Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulphonylureas, 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 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 Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lung infiltrates | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of fever and other signs of infection 2. Incidence and type of documented bacteremia 3. Rate of patients with systemic open-label antifungal therapy 4. Time to initiation of systemic open-label antifungal therapy 5. Duration of absolute neutrophil count <500/µl 6. Rate and type of proven, probable and possible breakthrough invasive fungal infections 7. Rate of patients with fever of unknown origin 8. Incidence and severity of adverse events 9. Trough voriconazole plasma level 10. Direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging 11. Overall costs in terms of the diagnosis related groups applied to the study patients | — |
Countries
Germany
Outcome results
None listed