Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Seoul National University

Status and phase: Enrolling; Phase 1

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Drug: Melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT04937634

SNUCH-MIDD-Mel

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Melphalan

Experimental group

Treatment:

Drug: Melphalan