Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

NCT04945954 | Unknown

• 1 other identifier: SNUH_MIDD_PTCy
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Cyclophosphamide

EXPERIMENTAL

Other: Drug: Cyclophosphamide

Interventions

Drug: Cyclophosphamide OTHER

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)

Cyclophosphamide

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Institute of Food and Drug Safety Evaluation (Republic of Korea): collaborator

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Hyoung Jin Kang, MD,PhD

  l

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hyoung Jin Kan, MD,PhD

CONTACT

+82-2-2072-3304; kanghj@snu.ac.kr

Kyung Taek Hong, MD,PhD

CONTACT

+82-2-2072-3631; hongkt@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 30, 2021

Record last verified: 2021-06