Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937634
• Other study ID #: SNUCH-MIDD-Mel
• Status: Recruiting
• Phase: Phase 1
• Start date: September 11, 2020
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: Hyoung Jin Kang, MD
• Phone: +82-2-2072-3452
• Email: kanghj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT).

• Age is below 19 at the time of diagnosis of a disease which is HSCT indication

• Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

• Female patients who are pregnant or breast feeding

• Study treatment would deteriorate patient's disease.

• The patient may have problems with study participation due to a psychotic disorder.

• Any condition that would, in the Investigator's judgement, interfere with participation in the study

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation

Intervention

Drug:
• Melphalan
The subject receives conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation. Dosage of melphalan is 50mg/m^2/day. Infuse Melphalan over 30 minutes.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melphalan concentration	Analysis: Maximum Concentration observed (Cmax)	pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
Primary	Melphalan concentration	Analysis: Time of Maximum concentration observed (Tmax)	pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
Primary	Melphalan concentration	Analysis: Area Under the Curve	pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
Primary	Melphalan concentration	Analysis: Half lite (T1/2)	pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI