Acute LeukemiaPhase 2NCT01472055
Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Fludarabine in people with Acute Leukemia and Chronic Leukemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia
- What is being tested?
- Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Sep 2014
- Phase
- Phase 2
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Conditioning regimen including fludarabine
- Age: < 19 years old
- Functional class: ECOG 0-2
- No loss of function of major organs. Criteria may be individualized.
- Heart: shortening fraction > 30%, ejection fraction > 45%.
- Liver: total bilirubin < 2 ⅹ upper limit of normal; ALT < 3 ⅹ upper limit of normal.
Show all 10Show fewer
- Kidney: creatinine < 2 ⅹ normal or a creatinine clearance (GFR) > 60 ml/min/1.73m2.
- No active viral or fungal infection
- Appropriate hematopoietic stem cell donor
- Informed consent from patients' parents
Who cannot join
- Pregnant or breast feeding
- Disease progression due to clinical test
- Psychiatric disease may interfere with clinical test
- Whether attending physician consider the patient inappropriate for study enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Daehangno, Jongno-gu
Hyoung Jin Kang, MD, PhD, +82 2 2072 0177, kanghj@snu.ac.kr
Ji Won Lee, MD, +82 2 2072 3452, agnesjw@hanmail.net
About this study
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
Read the detailed description
Fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. However, no pharmacokinetic study has thus far been conducted in pediatric patients. Fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. Pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients.
Through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics.
Through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free survival).
- Conditions
- Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia
- Being tested
- Fludarabine
- Keywords
- Hematopoietic stem cell transplantation with fludarabine based conditioning
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
- Fludarabine 40 mg/m^2 once a day intravenous administration over 30 min
- Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr
- Population pharmacokinetics analysis
- Comparative analysis of population pharmacokinetics in pediatric and adult patients
- Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine | Experimental | Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients Receives: Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Measured: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose
Secondary outcomes (3)
Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
Measured: 3 years
Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine
Measured: 1, 3, 6 and 12 months after transplantation
Evaluation of therapy related toxicity, significant adverse reaction
Measured: for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Investigators
- Hyoung Jin Kang, MD., PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472055
- Sponsor's protocol ID
- SNUCH-SCT-1101
- Status last verified
- Aug 2014
- First submitted
- 6 Nov 2011
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01472055
- Acronym / sponsor ID
- SNUCH-SCT-1101
- Conditions
- Acute Leukemia, Chronic Leukemia, Severe Aplastic Anemia
- Keywords
- Hematopoietic stem cell transplantation with fludarabine based conditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- Oct 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 16 Nov 2011 (estimated)
- 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.
The purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.
Detailed description
Fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. However, no pharmacokinetic study has thus far been conducted in pediatric patients. Fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. Pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients.
Through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics.
Through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free survival).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludarabine | Experimental | Drug: FludarabineAnalysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Conditioning regimen including fludarabine
- Age: < 19 years old
- Functional class: ECOG 0-2
- No loss of function of major organs. Criteria may be individualized.
- No active viral or fungal infection
Key exclusion criteria (4 listed)
- Pregnant or breast feeding
- Disease progression due to clinical test
- Psychiatric disease may interfere with clinical test
- Whether attending physician consider the patient inappropriate for study enrollment
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 |
|---|---|---|
| Fludarabine1. Fludarabine 40 mg/m^2 once a day intravenous administration over 30 min 2. Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr 3. Population pharmacokinetics analysis 4. Comparative analysis of population pharmacokinetics in pediatric and adult patients 5. Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate | Drug | Fludarabine |
Primary outcome
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients
Time frame: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose
3 secondary outcomes
Comparative analysis of the pharmacokinetics of fludarabine in pediatric and adult patients
Time frame: 3 years
Evaluation of toxicity, event free survival according to the pharmacokinetics of fludarabine
Time frame: 1, 3, 6 and 12 months after transplantation
Evaluation of therapy related toxicity, significant adverse reaction
Time frame: for 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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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
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 2 study testing Fludarabine in people with Acute Leukemia and Chronic Leukemia, 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 10 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 20 Aug 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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, PhD (+82 2 2072 0177, kanghj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients (time frame: 0hr (pre-dose), 30 min, 1, 3, 5, 8, 24hrs post-dose). 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 20 Aug 2014.