Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Sponsor

Zhujiang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04194086

Collaborator

Guangdong Provincial People's Hospital (Other)

Enrollment

Location

Arm

32.9

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Acute	Drug: posaconazole oral suspensions	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: posaconazole as antifungal prophylaxis	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.

Arm

Intervention/Treatment

Experimental: posaconazole as antifungal prophylaxis

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.

Outcome Measures

Primary Outcome Measures

Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0 [1 year]
Number, type and grade of adverse events of posaconazole oral suspensions to children with leukemia assessed by CTCAE v4.0.
Plasma posaconazole concentration monitoring and its pharmacokinetic [1 year]
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.

Secondary Outcome Measures

Serious Adverse events and drug-related adverse events monitoring [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital of Southern Medical University	Guanzhou	Guangdong	China

Sponsors and Collaborators

Zhujiang Hospital
Guangdong Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yang Lihua, Clinical Professor, Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT04194086

Other Study ID Numbers:

2018-EKZX-003

First Posted:

Dec 11, 2019

Last Update Posted:

Aug 3, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Posaconazole

Study Results

No Results Posted as of Aug 3, 2021