Status:
UNKNOWN
Pharmacokinetics Variability of Posaconazole (PCZ) and Its Glucuronide Metabolite During Induction and Consolidation Treatments in Patients With Acute Myeloid Leukemia (AML): a Covariate Analysis With the Tablets Formulation and Evaluation of the Potential Risk of Hepatotoxicity
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Among its authorized indications, posaconazole (PCZ) is prescribed for prophylaxis in onco-hematology patients at high risk of invasive fungal infections. This azole antifungal has a low bioavailabili...
Eligibility Criteria
Inclusion
- Patient aged 18 or over
- Patients with AML de novo or secondary to myelodysplastic syndrome or therapy-related AML except acute myeloid leukemia (AML3)
- Patient hospitalized for the treatment of leukemia (induction chemotherapy or consolidation)
- General state retained (ECOG performance scale ≤ 3)
- alanine aminotransferase aspartate transaminase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 2 times the ULN, creatinine \<150 μmol / L unless these biological abnormalities are related to leukemia
- Patients affiliated or beneficiaries of a social security scheme (Social Security or Universal Medical Coverage)
- Having read and understood the information sheet and signed the informed consent
Exclusion
- Patients with acute promyelocytic leukemia (AML3)
- History of uncontrolled cancer for at least two years
- Patient included in another clinical study that may interfere with the objectives of this study
- Treatment with antifungal other than posaconazole
- Severe uncontrolled infection at the time of inclusion
- Positive serology for HIV 1 or 2 or human T-cell lymphoma virus (HTLV 1) or 2, or active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Pregnant woman (beta positive HCG) or breastfeeding
- A woman of childbearing potential who can not justify the use of effective contraception during treatment with Noxafil®
- Patient incapacitated, under guardianship, curators or safeguard of justice
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03796533
Start Date
December 10 2018
End Date
April 10 2023
Last Update
February 24 2022
Active Locations (1)
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1
Centre Hospitalier Lyon Sud, Hematology department
Pierre-Bénite, France