Targeted Busulfan Fludarabine Etoposide Conditioning Regimen for HSCT in Childhood and Adolescent ALL.

  • End date
    Sep 26, 2023
  • participants needed
  • sponsor
    Seoul National University Hospital
Updated on 26 June 2021
ejection fraction
cell transplantation
transplant conditioning


To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent ALL.


Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Condition childhood ALL, leukemia, acute lymphoblastic, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute lymphoblastic leukemia, Lymphocytic Leukemia, Acute
Treatment busulfan
Clinical Study IdentifierNCT02047578
SponsorSeoul National University Hospital
Last Modified on26 June 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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