Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Phase 1

Recruiting

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Melphalan

• Registration Number: NCT04937634
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-11
• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melphalan	Melphalan	-

Primary Outcome Measures

Name	Time	Method
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: Half lite (T1/2)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of