KCT0009042
Recruiting
未知
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children.
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Samsung Medical Center
- Enrollment
- 116
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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