Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: National Institute of Food and Drug Safety Evaluation (Republic of Korea)
• Treatments: Melphalan

Criteria

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