Hematopoietic Stem Cell Transplantation
Conditions
Brief summary
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.
Interventions
OTHERDrug: Cyclophosphamide
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)
Sponsors
National Institute of Food and Drug Safety Evaluation (Republic of Korea)
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameter of melphalan | 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) | Analysis: Maximum plasma drug concentration (Cmax) |
Contacts
Primary Contacthyoung Jin Kan, MD,PhD
Backup ContactKyung Taek Hong, MD,PhD
Outcome results
None listed