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)

Phase 1

Conditions: prevention of invasive mould disease
MedDRA version: 20.0Level: LLTClassification code 10003488Term: AspergillosisSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2019-002408-42-GR

Lead Sponsor: ABORATOIRES SMB S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 462

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
dose of study drug for the prevention of IMD can be administered as
soon as possible within 5 days of the start of remission induction
chemotherapy. In ALL patients, as soon as possible 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.
5.Able to comply with all study procedures, including the use of inhalers
6.If patient is a female of childbearing potential (FOCP), patient must
agree to to abstain from sexual intercourse or to use an effective means
of birth control (oral contraceptives, intrauterine device [IUD], condoms
and spermicides, vaginal ring, hormonal patch, implants), as determined
by the Investigator from the first dose of study drug until 100 days
following the last dose of study drug. A female patient is considered to
be of childbearing potential if she has reached menarche and a) has not
undergone a hysterectomy (the surgical removal of the uterus) or
bilateral oophorectomy (the surgical removal of both ovaries), or b) has
not been postmenopausal for 12 consecutive months (i.e., has had
menses at any time during the preceding 12 months). Female patients of
childbearing potential must also provide a negative blood pregnancy test
at the Screening Visit. Male patients must be vasectomised, abstain from
sexual intercourse, or agree to use barrier contraception (condom with
spermicide), and also agree not to donate sperm from the first dose of
study drug until 100 days following the last dose of study drug.
7.Patients (and/or the patient's parents or legally authorised
representatives) must give written informed consent to participate in the
study by signing and dating the Informed Consent Form
(ICF)/Adolescent Assent Form (to be obtained prior to initiation of any
study procedure)
Are the trial subjects under 18? yes
Number of subjects for this age range: 23
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 339
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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
detection or =5 half-lives of the antifungal has elapsed since the
treatment was given.
5.Participating in another clinical trial with exposure to any
investigational drug within 30 days prior to Screening, with the
exception of the current anti-leukemic treatment
6.Pregnant or nursing females
7.Any severe co-morbidity other than underlying haematological disease
that may interfere with study procedures or affect the patient's safety
8.Grade 3 laspartate aminotransferase (ASAT >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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