Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Seoul National University Hospital20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematopoietic Stem Cell Transplantation

Interventions

MelphalanDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Melphalan concentration

Analysis: Maximum Concentration observed (Cmax)

Time frame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI

Melphalan concentration

Analysis: Time of Maximum concentration observed (Tmax)

Time frame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI

Melphalan concentration

Analysis: Area Under the Curve

Time frame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI

Melphalan concentration

Analysis: Half lite (T1/2)

Time frame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI

Central Contacts

Hyoung Jin Kang, MD

CONTACT

+82-2-2072-3452 kanghj@snu.ac.kr

Data from ClinicalTrials.gov

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