Study aiming at proving the efficacy, safety and tolerability of inhaled Itraconazole in the prevention of Invasive Mould Disease (infections of the lungs by fungi) in patients with Acute Leukaemia and Neutropaenia (abnormally low concentration of neutrophils in the blood)

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002408-42-GR

Enrollment

462

Registered

2019-12-27

Start date

2020-02-07

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prevention of invasive mould disease MedDRA version: 20.0 Level: LLT Classification code 10003488 Term: Aspergillosis System Organ Class: 100000004862

Interventions

Product Name: ITRACONAZOLE 4.8 mg Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: ITRACONAZOLE CAS Number: 84625-61-6 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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 5 × upper limit of normal (ULN), alanine aminotransferase (ALAT >5 × ULN, or total bilirubin >3 × ULN. 9.Any contraindication or hypersensitivity to the use of fluconazole or ITZ or the excipient (mannitol) in the study drug and placebo formulations 10.Co-administration of astemizole, atorvastatin, bepridil, cisapride, dihydroergotamine, dofetilide, eletriptan, ergometrine (erginovine), ergotamine, erythromycin, levacetylmethadol (levomethadyl), lovastatin, methylergometrine (methylergonovine), midazolam, mizolastine, nisoldipine, pimozide, quinidine, sertindole, simvastatin, terfenadine and triazolam. 11.Abnormal QT interval corrected by Fridericia (QTcF): males >450 ms and females >470 ms

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether prophylaxis with ITZ DPI can reduce the incidence rate of IMD in patients with acute leukaemia undergoing remission induction chemotherapy;Secondary Objective: -To investigate the safety and tolerability of ITZ DPI in patients with acute leukaemia undergoing remission-induction chemotherapy -To evaluate the PK of ITZ DPI in patients with acute leukaemia undergoing remission induction chemotherapy ;Primary end point(s): •Proportion of patients with proven or probable IMD at EOT. Diagnoses of proven or probable IMD will be evaluated according to 2019 EORTC/MSGERC criteria, as assessed by the Independent Data Review Board (IDRB) that will be blinded to treatment assignment.;Timepoint(s) of evaluation of this end point: End of treatment	—

Measure

Time frame

Main Objective: To investigate whether prophylaxis with ITZ DPI can reduce the incidence rate of IMD in patients with acute leukaemia undergoing remission induction chemotherapy;Secondary Objective: -To investigate the safety and tolerability of ITZ DPI in patients with acute leukaemia undergoing remission-induction chemotherapy -To evaluate the PK of ITZ DPI in patients with acute leukaemia undergoing remission induction chemotherapy ;Primary end point(s): •Proportion of patients with proven or probable IMD at EOT. Diagnoses of proven or probable IMD will be evaluated according to 2019 EORTC/MSGERC criteria, as assessed by the Independent Data Review Board (IDRB) that will be blinded to treatment assignment.;Timepoint(s) of evaluation of this end point: End of treatment

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy endpoints are: •Treatment success at EOT (success defined as patients who completed treatment without developing a proven, probable, or possible IMD, without requiring systemic mould-active antifungal treatment, without discontinuation from the study due to an adverse event [AE], and who are alive). •The proportion of patients: owith proven, probable, or possible IMD at EOT and EOS o who had neutropaenia =10 days and with proven, probable, or possible IMD at EOT and EOS o with radiographic pulmonary infiltrates according to the central image reader at EOT and EOS o with bronchopulmonary aspergillosis at EOT and EOS o with fungal sinusitis at EOT and EOS o with proven or probable or possible IA at EOT and at EOS o with candidemia/candidiasis at EOT and EOS o requiring systemic mould-active antifungal treatment at EOT and EOS to treat a breakthrough fungal disease o alive at EOT and EOS o who died at EOT and EOS due to IMD or IA o in complete remission of their underlying malignancy at EOT and EOS •The proportion of pathogenic moulds causing proven and probable IMDs at EOT and EOS •Time to: o diagnosis of proven, probable, or possible IMD o diagnosis of IA o the onset of systemic mould-active antifungal treatment for a breakthrough fungal disease o death of any cause;Timepoint(s) of evaluation of this end point: End of treatment and end of study	—

Measure

Time frame

Secondary end point(s): The secondary efficacy endpoints are: •Treatment success at EOT (success defined as patients who completed treatment without developing a proven, probable, or possible IMD, without requiring systemic mould-active antifungal treatment, without discontinuation from the study due to an adverse event [AE], and who are alive). •The proportion of patients: owith proven, probable, or possible IMD at EOT and EOS o who had neutropaenia =10 days and with proven, probable, or possible IMD at EOT and EOS o with radiographic pulmonary infiltrates according to the central image reader at EOT and EOS o with bronchopulmonary aspergillosis at EOT and EOS o with fungal sinusitis at EOT and EOS o with proven or probable or possible IA at EOT and at EOS o with candidemia/candidiasis at EOT and EOS o requiring systemic mould-active antifungal treatment at EOT and EOS to treat a breakthrough fungal disease o alive at EOT and EOS o who died at EOT and EOS due to IMD or IA o in complete remission of their underlying malignancy at EOT and EOS •The proportion of pathogenic moulds causing proven and probable IMDs at EOT and EOS •Time to: o diagnosis of proven, probable, or possible IMD o diagnosis of IA o the onset of systemic mould-active antifungal treatment for a breakthrough fungal disease o death of any cause;Timepoint(s) of evaluation of this end point: End of treatment and end of study

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Countries

Belgium, Bulgaria, Greece, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine

Contacts

Public ContactCLINICAL DEPARTMENT

LABORATOIRES SMB S.A

Dpt_Clinique@smb.be+322411 48 28

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026