Hematopoietic Stem Cell Transplantation
Conditions
Brief summary
This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.
Interventions
DRUGMelphalan
The subject receives conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation. Dosage of melphalan is 50mg/m\^2/day. Infuse Melphalan over 30 minutes.
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
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT). * Age is below 19 at the time of diagnosis of a disease which is HSCT indication * Written Study Informed consent and/or assent from the patient, parent, or guardian
Exclusion criteria
* Female patients who are pregnant or breast feeding * Study treatment would deteriorate patient's disease. * The patient may have problems with study participation due to a psychotic disorder. * Any condition that would, in the Investigator's judgement, interfere with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melphalan concentration | pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI | Analysis: Maximum Concentration observed (Cmax) |
Countries
South Korea
Contacts
Primary ContactHyoung Jin Kang, MD
Outcome results
None listed