Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04945954

Collaborator

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

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation	Other: Drug: Cyclophosphamide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclophosphamide	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)

Arm

Intervention/Treatment

Experimental: Cyclophosphamide

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)

Outcome Measures

Primary Outcome Measures

Pharmacokinetics parameter of melphalan [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)
Pharmacokinetics parameter of melphalan [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)
Pharmacokinetics parameter of melphalan [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Hyoung Jin Kang, MD,PhD, l

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyoung Jin Kang, professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04945954

Other Study ID Numbers:

SNUH_MIDD_PTCy

First Posted:

Jun 30, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cyclophosphamide

Study Results

No Results Posted as of Jun 30, 2021