Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04937634
Other study ID # SNUCH-MIDD-Mel
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00766883 - Problem-Solving Education for Caregivers and Patients During Stem Cell Transplant Phase 2
Recruiting NCT06148610 - Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Completed NCT02564458 - Fitness in Allogeneic Stem Cell Transplantation N/A
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Not yet recruiting NCT01714557 - Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation N/A
Completed NCT00701688 - Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Phase 1
Completed NCT00023530 - Blood and Marrow Transplant Clinical Research Network N/A
Recruiting NCT04092309 - Effect of Angiotensin Converting Enzyme and Sacubitril Valsartan in Patients After Bone Marrow Transplantation N/A
Completed NCT00000603 - Cord Blood Stem Cell Transplantation Study (COBLT) Phase 2
Completed NCT02663622 - Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) Phase 2
Recruiting NCT04203108 - ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis Phase 4
Completed NCT03654599 - Effects of Digital Stories Intervention on Psychosocial Well-being N/A
Withdrawn NCT03279133 - Ledipasvir/Sofosbuvir Treatment for Hepatitis C in HCT Recipients. Phase 4
Completed NCT05151406 - Myths and Misconceptions About HSCT in a Limited Resource Region N/A
Completed NCT02241005 - Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci N/A
Recruiting NCT03689465 - PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis Phase 4
Recruiting NCT04868786 - Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation Phase 1
Recruiting NCT03010579 - Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation Phase 4
Active, not recruiting NCT00959140 - Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors N/A