Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04945954
• Other study ID #: SNUH_MIDD_PTCy
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: June 2024

Study information

• Verified date: June 2021
• Source: Seoul National University Hospital
• Contact: hyoung Jin Kan, MD,PhD
• Phone: +82-2-2072-3304
• Email: kanghj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation

Intervention

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Institute of Food and Drug Safety Evaluation (Republic of Korea)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameter of melphalan	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)
Primary	Pharmacokinetics parameter of melphalan	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)
Primary	Pharmacokinetics parameter of melphalan	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)