Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
1 other identifier
interventional
27
1 country
1
Brief Summary
In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 19, 2013
November 1, 2013
2.9 years
January 10, 2011
November 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation
Secondary Outcomes (1)
To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate.
1, 3, 6 and 12 months after transplantation
Study Arms (1)
Busulfan
EXPERIMENTALInterventions
First dose: busulfan (120 mg/m2 ivs once daily) (if age\<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
Eligibility Criteria
You may qualify if:
- Patients who are diagnosed as AML.
- Patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen.
- Age: up to 21 years
- Performance status: ECOG 0-2.
- Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
- Patients must lack any active viral infections or active fungal infection.
- Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
- Patients (or one of parents if patients age \< 20) should sign informed consent.
You may not qualify if:
- Pregnant or nursing women.
- Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- Psychiatric disorder that would preclude compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Daehangno, Jongno-gu, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyoung Jin Kang, M.D., Ph.D
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2011
First Posted
January 11, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
November 19, 2013
Record last verified: 2013-11