Hematopoietic Stem Cell TransplantationPhase 1NCT04937634
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
A Phase 1 study testing Melphalan in people with Hematopoietic Stem Cell Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Melphalan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2020to Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyoung Jin Kang, MD, PhD
About this study
This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Melphalan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Conditioning regimen including melphalan for hematopoietic stem cell transplantation
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.
| Study group | Role | What they receive |
|---|---|---|
| Melphalan | Experimental | Not described Receives: Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melphalan concentration
Analysis: Maximum Concentration observed (Cmax)
Measured: 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)
Measured: 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
Measured: 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)
Measured: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start11 Sep 2020
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Food and Drug Safety Evaluation (Republic of Korea)
- Responsible party
- Sponsor
- Investigators
- Hyoung Jin Kang, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937634
- Sponsor's protocol ID
- SNUCH-MIDD-Mel
- Status last verified
- Jan 2023
- First submitted
- 28 Mar 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Choi JY, Kim B, Park HJ, Kim BK, Hong KT, Lee S, Lee S, Kang HJ. Population Pharmacokinetics of Melphalan in Pediatric Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation with Various Conditioning Regimens. Eur J Drug Metab Pharmacokinet. 2026 Jul;51(4):391-400. doi: 10.1007/s13318-026-01000-6. Epub 2026 Apr 29.
PubMed 42053946
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04937634
- Acronym / sponsor ID
- SNUCH-MIDD-Mel
- Conditions
- Hematopoietic Stem Cell Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Food and Drug Safety Evaluation (Republic of Korea)
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melphalan | Experimental | Drug: Melphalan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelphalanAlso: Conditioning regimen including melphalan for hematopoietic stem cell transplantationThe 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. | Drug | Melphalan |
Primary outcome
Melphalan concentration
Time frame: 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)
Melphalan concentration
Time frame: 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)
Melphalan concentration
Time frame: 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
Melphalan concentration
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 42053946Choi JY, Kim B, Park HJ, Kim BK, Hong KT, Lee S, Lee S, Kang HJ. Population Pharmacokinetics of Melphalan in Pediatric Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation with Various Conditioning Regimens. Eur J Drug Metab Pharmacokinet. 2026 Jul;51(4):391-400. doi: 10.1007/s13318-026-01000-6. Epub 2026 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung Jin Kang, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melphalan in people with Hematopoietic Stem Cell Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyoung Jin Kang, MD (+82-2-2072-3452, kanghj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melphalan concentration (time frame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.