Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
Not Applicable
- Conditions
- Hematopoietic Stem Cell Transplantation
- Registration Number
- NCT04945954
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pharmacokinetics parameter of melphalan 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) Analysis: Area under the plasma concentration-time curve (AUC)
- Secondary Outcome Measures
Name Time Method