Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
NCT ID: NCT04945954
Last Updated: 2021-06-30
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
NA
15 participants
INTERVENTIONAL
2021-06-30
2024-06-30
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
PREVENTION
NONE
Study Groups
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Cyclophosphamide
Drug: Cyclophosphamide
Administer 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously)
Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD)
Interventions
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Drug: Cyclophosphamide
Administer 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously)
Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD)
Eligibility Criteria
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Inclusion Criteria
* Patients age \<19 years
* Written Study Informed consent and/or assent from the patient, parent, or guardian
Exclusion Criteria
* Patients in a medically critical condition such as severe infection or unstable vital signs
* Any condition that would, in the Investigator's judgment, interfere with full participation in the study
* Subjects who are pregnant or breast-feeding
* Subjects with psychiatric conditions that may interfere with the study
* Subjects who have a possibility of the disease getting worse as a treatment for clinical trials
18 Years
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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Hyoung Jin Kang
professor
Principal Investigators
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Hyoung Jin Kang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
l
Central Contacts
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Other Identifiers
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SNUH_MIDD_PTCy
Identifier Type: -
Identifier Source: org_study_id