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โ† Trials
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Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

RecruitingPhase 2Ages 1 Year - 9 YearsAllHee Young Ju
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In plain words

What the trial is, and whether it could suit you

Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
\<Inclusion Criteria\> * Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following 1. 1 year old โ‰ค Age \< 10 years old 2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL) 3. No testis involvement 4. Satisfaction of following organ functions A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) โ‰ฅ 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, โ‰ฅ 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 \<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. Newly diagnosed T cell ALL 4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome 5. Burkitt leukemia/lymphoma 6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome 7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
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What it tests

  • induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
  • Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
  • Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
  • Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
  • Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
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Where

13 sites
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Kyungpook National University Chilgok-Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Jeju National University Hospital
Jeju City, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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