Clincosm LogoSign in Get a demo

Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04937634
Collaborator
National Institute of Food and Drug Safety Evaluation (Republic of Korea) (Other)
20
Enrollment
1
Location
1
Arm
35.6
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Sep 11, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melphalan

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.
Other Names:
  • Conditioning regimen including melphalan for hematopoietic stem cell transplantation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Melphalan concentration [pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI]

      Analysis: Maximum Concentration observed (Cmax)

    2. Melphalan concentration [pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI]

      Analysis: Time of Maximum concentration observed (Tmax)

    3. Melphalan concentration [pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI]

      Analysis: Area Under the Curve

    4. Melphalan concentration [pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI]

      Analysis: Half lite (T1/2)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Hyoung Jin Kang, MD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT04937634
    Other Study ID Numbers:
    • SNUCH-MIDD-Mel
    First Posted:
    Jun 24, 2021
    Last Update Posted:
    Jun 24, 2021
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Melphalan

    Study Results

    No Results Posted as of Jun 24, 2021