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临床试验/NCT06184009
NCT06184009招募中2 期

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study

Jae Wook Lee10 个研究点 分布在 2 个国家目标入组 370 人开始时间: 2024年8月10日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
370
试验地点
10
主要终点
Event Free Survival
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

  • Clinical and genetic factors consistent with High risk : Induction → Consolidation
  1. BM MRD < 0.01% : IM #1 → DI #1 → IM #2 → Maintenance
  2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
  3. BM MRD ≥ 0.01% after Consolidation

  1. T cell ALL : Change to very high risk regimen

  2. Pre-B ALL : IM #1 → Intensification

  3. BM MRD < 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance

  4. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen

  • Difference in the number of 'interim maintenance(IM)' and 'delayed intensification(DI)' is important for chemotherapies based on MRD.

详细描述

  • Clinical and genetic factors consistent with High risk : Induction → Consolidation
  1. BM MRD < 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
  2. BM MRD ≥ 0.01% after Induction, < 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
  3. BM MRD ≥ 0.01% after Consolidation

  1. T cell ALL : Change to very high risk regimen

  2. Pre-B ALL : IM #1 → Intensification

  3. BM MRD < 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance

  4. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 19 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •\ * Age: 1year\~19years of age at diagnosis
  • •* Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
  • •* High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10\^9/L at diagnosis
  • •* If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
  • •* High-risk gene variants:
  • •KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21)
  • •● If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification.
  • •* Newly diagnosed T cell ALL

排除标准

  • •Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
  • •Patients with Down syndrome
  • •potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
  • •Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
  • •Participating in an interventional clinical trial other than this research

研究组 & 干预措施

ALL, High risk with DI #2(Doxorubicin)

Experimental
  • Clinical and genetic factors consistent with High risk : Induction → Consolidation
  1. BM MRD < 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
  2. BM MRD ≥ 0.01% after Induction, < 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
  3. BM MRD ≥ 0.01% after Consolidation

  1. T cell ALL : Change to very high risk regimen

  2. Pre-B ALL : IM #1 → Intensification

  3. BM MRD < 0.01% after IM #1 : Continue with 'No. 2' of High risk regimen starting with DI #1

  4. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen

  • T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.

干预措施: ALL, High risk (Drug)

结局指标

主要结局

Event Free Survival

时间窗: Up to 5 years

Event-free survival rate for 5 years from the date of registration

次要结局

  • Overall Survival(Up to 5 years)
  • Recurred rate(Up to 5 years)
  • Death rate related to infusion(Up to 5 years)

研究者

发起方
Jae Wook Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jae Wook Lee

Principal Investigator

Seoul St. Mary's Hospital

研究点 (10)

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