临床试验/NCT06099366

NCT06099366招募中2 期

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

Hee Young Ju15 个研究点分布在 2 个国家目标入组 116 人开始时间: 2024年3月5日最近更新: 2026年7月29日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 116
试验地点: 15
主要终点: 5-year event free survival rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 1 Year 至 9 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•\ * Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
•1. 1 year old ≤ 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) ≥ 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

排除标准

•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

研究组 & 干预措施

Standard-low (SL)

Experimental

Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate (Drug)

Standard-low (SL)

Experimental

Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate (Drug)

Standard-low (SL)

Experimental

Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate (Drug)

Standard-low (SL)

Experimental

Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate (Drug)

Standard-low (SL)

Experimental

Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate (Drug)

Standard-average (SA)

Experimental

Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate (Drug)

Standard-average (SA)

Experimental

Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate (Drug)

Standard-average (SA)

Experimental

Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate (Drug)

Standard-average (SA)

Experimental

Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate (Drug)

Standard-average (SA)

Experimental

Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance

干预措施: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate (Drug)