Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children.

Samsung Medical Center0 个研究点目标入组 116 人开始时间: 待定最近更新: 2024年5月27日

适应症

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•Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following
•1 year old = Age < 10 years old
•2. white blood cell at initial diagnosis < 50 X 10³/µL (50,000uL)
•3. CNS 1 or 2
•4. No testis involvement
•5. Satisfaction of following organ functions
•A. Kidney function (satisfies i or ii)
•i. Creatinine clearance (or radioisotope-measured GFR) = 70mL/min/1.73m2
•ii. Creatinine value according to age/sec satisfies the following:
•1 to < 2 years: Male: 0.6 / Female: 0.6
•2 to < 6 years: Male: 0.8 / Female: 0.8
•6 to < 10 years: Male: 1 / Female: 1
•10 to < 13 years: Male: 1.2 / Female: 1.2
•13 to < 16 years: Male: 1.5 / Female: 1.4
•= 16 years: Male: 1.7 / Female: 1.4
•However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.
•B. Liver function i. Direct bilirubin < 3.0mg/dL
•C. Cardiac function
•i. Shortening fraction = 27% confirmed by cardiac echography
•ii. Ejection fraction = 50% confirmed by cardiac echography

•1. Steroid administration within 2 weeks before the registration
•2. t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF
•3. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
•4. Burkitt leukemia/lymphoma or mature B-cell leukemia
•5. When the clinical trial subject(or legal representative) does not consent or is unable to give written consen

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