Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Study Overview
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Brief Summary
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This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.

Official Title
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Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Conditions
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Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Other: Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation Patients age <19 years Written Study Informed consent and/or assent from the patient, parent, or guardian Exclusion Criteria: Known hypersensitivity to mycophenolate mofetil or similar class of drug substance Patients in a medically critical condition such as severe infection or unstable vital signs Any condition that would, in the Investigator's judgment, interfere with full participation in the study Subjects who are pregnant or breast-feeding Subjects with psychiatric conditions that may interfere with the study Subjects who have a possibility of the disease getting worse as a treatment for clinical trials

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclophosphamide<br> | Other: Drug: Cyclophosphamide<br>* Administer 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously) Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter of melphalan | Analysis: Maximum plasma drug concentration (Cmax) | Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT) | 
| Pharmacokinetics parameter of melphalan | Analysis: Maximum plasma drug concentration (Cmax) | Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT) | 
| Pharmacokinetics parameter of melphalan | Analysis: Area under the plasma concentration-time curve (AUC) | D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT) |