ASPER III-09-01

A Phase 3, Double-Blind, Multicentric, randomized, placebo-controlled study to assess the efficacy, safety and tolerability of Itraconazole-Dry Powder for inhalation for the prevention of Invasive Mold Disease in patients with Acute Leukemia and Neutropenia

Study treatments

Itraconazole Dry Powder for Inhalation

Inclusion criteria

• Male or female patients ≥12 years of age
• New or relapsed ALL or AML who can’t receive posaconazole and who are to undergo remission-induction chemotherapy - Current neutropenia resulting from the diagnosis of acute leukemia or patients with expected neutropenia for at least 10 days (ANC<500 cell/mm3) following remission-induction chemotherapy 
• Able to have all Screening tests performed quickly to ensure results can be obtained and evaluated before randomization, so that the first dose of study drug for the prevention of IMD can be administered within 5 days of the start of remission-induction chemotherapy. In ALL patients, within 5 days of the start of remission-induction chemotherapy means as soon as possible within 5 days of the start of high-dose steroid therapy

Exclusion criteria

• Proven, probable, or possible IMD at Screening or in the patient’s medical history
• Pulmonary complications or infiltrates assessed by a chest CT
• Patients with ventricular dysfunction defined as ejection fraction <55% at Screening
• Concomitant or previous treatment with a mould-active antifungal drug within 30 days, unless the plasma level is below the limit of detection or ≥5 half-lives of the antifungal has elapsed since the treatment was given.
• Grade 3 liver function test results, including aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), or total bilirubin >5 times the upper limit of normal (ULN) - Any contraindication or hypersensitivity to the use of fluconazole or ITZ or the excipient (mannitol) in the study drug and placebo formulation

Participating sites

• University Hospital Leuven Gasthuisberg