Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

NCT04937634 | Unknown Phase 1 FDA Drug

• 1 other identifier: SNUCH-MIDD-Mel
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Melphalan

EXPERIMENTAL

Drug: Melphalan

Interventions

Melphalan DRUG

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.

Also known as: Conditioning regimen including melphalan for hematopoietic stem cell transplantation

Melphalan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Interventions

Melphalan; Hematopoietic Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Hyoung Jin Kang, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung Jin Kang, MD

CONTACT

+82-2-2072-3452; kanghj@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: June 24, 2021
• Study Start: September 11, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

KR (1)