EUCTR2019-002408-42-GR
Active, not recruiting
Phase 1
A Phase 3, Double Blind, Multicentric, Randomised, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Itraconazole Dry Powder for Inhalation for the Prevention of Invasive Mould Disease in Patients with Acute Leukaemia and Neutropaenia
ABORATOIRES SMB S.A.0 sites462 target enrollmentDecember 27, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- prevention of invasive mould disease
- Sponsor
- ABORATOIRES SMB S.A.
- Enrollment
- 462
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female patients \=12 years of age
- •2\.Patients with new or relapsed ALL or AML who cannot receive
- •posaconazole for any reason and who are to undergo remissioninduction
- •chemotherapy
- •3\.Current neutropaenia resulting from the diagnosis of new or relapsed
- •acute leukaemia or patients with expected neutropaenia for at least 10
- •days (an absolute neutrophil count \<500 cell/mm3 or 0\.5 x 109 cell/L)
- •following remission\-induction chemotherapy
- •4\.Able to have all Screening tests performed quickly to ensure results
- •can be obtained and evaluated before randomisation, so that the first
Exclusion Criteria
- •1\.Proven, probable, or possible IMD (according to 2019 European
- •Organisation for Research and Treatment of Cancer/Mycoses Study
- •Group Education and Research Consortium \[EORTC/MSGMSGERC]
- •criteria at Screening or in the patient's medical history
- •2\.Pulmonary complications or active infiltrates associated with an
- •ongoing pulmonary disease assessed by a chest CT
- •3\.Patients with ventricular dysfunction defined as ejection fraction
- •\<55% at Screening
- •4\.Concomitant or previous treatment with a mould\-active antifungal
- •drug within 30 days, unless the plasma level is below the limit of
Outcomes
Primary Outcomes
Not specified
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