Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
June 22, 2021 updated by: Hyoung Jin Kang, Seoul National University Hospital
This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: hyoung Jin Kan, MD,PhD
- Phone Number: +82-2-2072-3304
- Email: kanghj@snu.ac.kr
Study Contact Backup
- Name: Kyung Taek Hong, MD,PhD
- Phone Number: +82-2-2072-3631
- Email: hongkt@snu.ac.kr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation
- Patients age <19 years
- Written Study Informed consent and/or assent from the patient, parent, or guardian
Exclusion Criteria:
- Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics parameter of melphalan
Time Frame: Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)
|
Analysis: Maximum plasma drug concentration (Cmax)
|
Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)
|
|
Pharmacokinetics parameter of melphalan
Time Frame: Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT)
|
Analysis: Maximum plasma drug concentration (Cmax)
|
Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT)
|
|
Pharmacokinetics parameter of melphalan
Time Frame: D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT)
|
Analysis: Area under the plasma concentration-time curve (AUC)
|
D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hyoung Jin Kang, MD,PhD, l
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 22, 2021
First Posted (Actual)
June 30, 2021
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 22, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUH_MIDD_PTCy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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