KCT0009042招募中Unknown
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1(Year) 至 9(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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