Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients

Seoul National University

Status: Not yet enrolling

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Other: Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT04945954

SNUH_MIDD_PTCy

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Cyclophosphamide

Experimental group

Treatment:

Other: Drug: Cyclophosphamide