Hematopoietic Stem Cell TransplantationNCT04945954
Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
A study testing Drug: Cyclophosphamide in people with Hematopoietic Stem Cell Transplantation, run by Seoul National University Hospital.
Trial summary
This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Drug: Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2024
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation
- Patients age <19 years
- Written Study Informed consent and/or assent from the patient, parent, or guardian
Who cannot join
- Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
- Patients in a medically critical condition such as severe infection or unstable vital signs
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study
- Subjects who are pregnant or breast-feeding
- Subjects with psychiatric conditions that may interfere with the study
- Subjects who have a possibility of the disease getting worse as a treatment for clinical trials
Trial locations and contacts
No sites are listed yet.
About this study
This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- Drug: Cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: CyclophosphamideOther
Administer 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously)
Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD)
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide | Experimental | Not described Receives: Other: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter of melphalan
Analysis: Maximum plasma drug concentration (Cmax)
Measured: Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)
Pharmacokinetics parameter of melphalan
Analysis: Maximum plasma drug concentration (Cmax)
Measured: Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT)
Pharmacokinetics parameter of melphalan
Analysis: Area under the plasma concentration-time curve (AUC)
Measured: D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- Principal investigator, Hyoung Jin Kang, Seoul National University Hospital
- Investigators
- Hyoung Jin Kang, MD,PhD, Principal investigator, l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945954
- Sponsor's protocol ID
- SNUH_MIDD_PTCy
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04945954
- Acronym / sponsor ID
- SNUH_MIDD_PTCy
- Conditions
- Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 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
- Jun 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 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 population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide | Experimental | Other: Drug: Cyclophosphamide |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation
- Patients age <19 years
- Written Study Informed consent and/or assent from the patient, parent, or guardian
Key exclusion criteria (6 listed)
- Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
- Patients in a medically critical condition such as severe infection or unstable vital signs
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study
- Subjects who are pregnant or breast-feeding
- Subjects with psychiatric conditions that may interfere with 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 |
|---|---|---|
| Drug: CyclophosphamideAdminister 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously) Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD) | Other | Cyclophosphamide |
Primary outcome
Pharmacokinetics parameter of melphalan
Time frame: Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)
Analysis: Maximum plasma drug concentration (Cmax)
Pharmacokinetics parameter of melphalan
Time frame: Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT)
Analysis: Maximum plasma drug concentration (Cmax)
Pharmacokinetics parameter of melphalan
Time frame: D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT)
Analysis: Area under the plasma concentration-time curve (AUC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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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,PhD principal investigator
l
Questions about this trial
What is this clinical trial studying?
A study testing Drug: Cyclophosphamide in people with Hematopoietic Stem Cell Transplantation, run by Seoul National University Hospital.
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 6 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 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Kan, MD,PhD (+82-2-2072-3304, kanghj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameter of melphalan (time frame: Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2021.