Targeted Busulfan, Fludarabine, Etoposide Conditioning Regimen for HSCT in Childhood and Adolescent ALL.
1 other identifier
interventional
38
1 country
1
Brief Summary
To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2014
Longer than P75 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
First Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedStudy Start
First participant enrolled
February 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 6, 2023
January 1, 2023
9.8 years
January 9, 2014
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-year event free survival after hematopoietic stem cell transplantation.
To evaluate 1-year event free survival after hematopoietic stem cell transplantation.
at 1 year
Secondary Outcomes (1)
Engraftment rate
1, 3, 6 and 12 months after transplantation
Other Outcomes (5)
Toxicities associated with hematopoietic stem cell transplantation
1, 3, 6 and 12 months after transplantation
Acute GVHD
1, 3, 6 and 12 months after transplantation
Chronic GVHD
1, 3, 6 and 12 months after transplantation
- +2 more other outcomes
Study Arms (1)
Busulfan
EXPERIMENTALDrug: Busulfan 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
Interventions
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 ALL.
- Patients who need hematopoietic stem cell transplantation
- 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 \< 19) 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
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyoung Jin Kang, MD, PhD
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 28, 2014
Study Start
February 5, 2014
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 6, 2023
Record last verified: 2023-01