Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Официальное название

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

Обзор

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.

Вмешательства

• Препарат induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
  vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
• Препарат Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate
• Препарат Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
• Препарат Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
• Препарат Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
• Препарат Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate
• Препарат Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
• Препарат Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
  Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Первичные конечные точки

• 5-year event free survival rate [Срок оценки: Up to 5-years]

Вторичные конечные точки (2)

• Confirmation of the therapeutic effect of the initial treatment response [Срок оценки: Up to 5-years]
• Disease prognosis-related factor [Срок оценки: Up to 5-years]

Критерии участия

<Inclusion Criteria>

• Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following

• 1 year old ≤ Age < 10 years old
• white blood cell at initial diagnosis < 5x10\^10/L (50,000uL)
• No testis involvement
• 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

<Exclusion Criteria>

• Steroid administration within 2 weeks before the registration
• t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF
• Newly diagnosed T cell ALL
• One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
• Burkitt leukemia/lymphoma
• In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
• When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 13 центров

• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul
• Pusan National University Yangsan Hospital — Yangsan
• Kyungpook National University Chilgok-Hospital — Daegu
• Chungnam National University Hospital — Daejeon
• Chonnam National University Hwasun Hospital — Hwasun
• Jeju National University Hospital — Jeju City
• Seoul National University Bundang Hospital — Seongnam
• … и ещё 5 центров

Идентификаторы

NCT: NCT06099366 · 2023-09-142

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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