Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Seoul National University Hospital15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hematopoietic Stem Cell Transplantation

Interventions

Drug: CyclophosphamideOTHER

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)

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetics parameter of melphalan

Analysis: Maximum plasma drug concentration (Cmax)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Central Contacts

hyoung Jin Kan, MD,PhD

CONTACT

+82-2-2072-3304 kanghj@snu.ac.kr

Kyung Taek Hong, MD,PhD

CONTACT

+82-2-2072-3631 hongkt@snu.ac.kr

Data from ClinicalTrials.gov

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