Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Leukemia, Acute Clinical Trial

Official title:

Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194086
• Other study ID #: 2018-EKZX-003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.

Description:

Posaconazole as a new triazole antifungal agent with broad spectrum coverage, was recommended for prophylaxis of invasive fungal disease in adults. Some studies have demonstrated the relationship between posaconazole plasma concentration and efficacy and few data have been published in children with leukemia.The purpose of this study is to describe the off-label use of posaconazole oral suspensions in children;to figure out the relationship between concentration and clinical outcomes/ adverse events;to identify factors that influence plasma concentration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 30, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

• 1?Patients age 2-14 years with acute leukemia (AML, ALL) undergoing chemotherapy and neutropenia expected to last at least 7 days.

2?Karnofsky/Lansky score of 60% or greater. 3?defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN),aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.

4?No other treatment and combination of triazoles antifungals and drugs like vincristine, sirolimus, cyclosporine etc.

5?Able to take oral medication or take medication via enteral feeding tube. 6?Ability to give informed consent. 7?No history of anaphylaxis attributed to the azole class of antifungal agents.

Exclusion Criteria:

• 1?Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction.

2?Subject is not considered eligible for this clinical research program with posaconazole.

3?Use of medications that are known to interact with posaconazole and that may lead to life-threatening side to effects.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Acute

Intervention

Drug:
• posaconazole oral suspensions
posaconazole oral suspensions(5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guanzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0	Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.	1 year
Primary	Plasma posaconazole concentration monitoring and its pharmacokinetic	Blood samples for determination of plasma posaconazole concentration will be collected predoses (just prior to a daily dose) on days 3, 7, 14 and 21. Anther concentration (include peak concentraton) will also be collected at least 7days after the first dose.	1 year
Secondary	Serious Adverse events and drug-related adverse events monitoring		2 years