Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia (NCT04194086) | Clinical Trial Compass
CompletedPhase 1/2
Population Pharmacokinetics and Safety of Oral Posaconazole in Children With Leukemia
China42 participantsStarted 2018-11-01
Plain-language summary
This study is designed to evaluate the safety, efficacy and Population Pharmacokinetics of Oral Posaconazole in Children with leukemia.
Who can participate
Age range
2 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number, type and grade of adverse events of posaconazole assessed by CTCAE v4.0
Timeframe: 1 year
2
Plasma posaconazole concentration monitoring and its pharmacokinetic