Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Lymphoblastic Leukemia in Children. Basic parameters: 1 year — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
Overview
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.
Interventions
- Drug 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 - Drug 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 - Drug 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 - Drug Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate - Drug Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate - Drug 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 - Drug 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 - Drug Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Primary outcome measures
- 5-year event free survival rate [Time frame: Up to 5-years]
Secondary outcome measures (2)
- Confirmation of the therapeutic effect of the initial treatment response [Time frame: Up to 5-years]
- Disease prognosis-related factor [Time frame: Up to 5-years]
Eligibility criteria
<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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 13 centers
- 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
- … and 5 more centers
Identifiers
NCT: NCT06099366 · 2023-09-142