Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
NCT ID: NCT04937634
Last Updated: 2023-02-06
Study Results
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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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2020-09-11
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Melphalan
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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National Institute of Food and Drug Safety Evaluation (Republic of Korea)
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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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