UnknownPhase 2

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

South Korea38 participantsStarted 2014-02-05

Plain-language summary

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

Who can participate

Age range21 Years

SexALL

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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.

What they're measuring

1-year event free survival after hematopoietic stem cell transplantation.

Timeframe: at 1 year

Trial details

NCT IDNCT02047578

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Hyoung Jin Kang, MD, PhD

82 2 2072 3304 kanghj@snu.ac.kr

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials