Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

NCT ID: NCT04937634

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2023-09-30

Brief Summary

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

Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Melphalan

Group Type EXPERIMENTAL

Melphalan

Intervention Type DRUG

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.

Interventions

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Melphalan

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.

Intervention Type DRUG

Other Intervention Names

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Conditioning regimen including melphalan for hematopoietic stem cell transplantation

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Food and Drug Safety Evaluation (Republic of Korea)

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyoung Jin Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyoung Jin Kang, MD

Role: CONTACT

+82-2-2072-3452

Facility Contacts

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Hyoung Jin Kang, MD, PhD

Role: primary

Other Identifiers

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SNUCH-MIDD-Mel

Identifier Type: -

Identifier Source: org_study_id

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