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Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

NCT04945954 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-30

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hyoung Jin Kang, MD,PhD · l

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2024-06-30
Completion
2024-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945954 on ClinicalTrials.gov