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临床试验/NCT06257394
NCT06257394招募中2 期

Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Hyoung Jin Kang11 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2024年10月20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
74
试验地点
11
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

Very high-risk acute lymphoblastic leukemia

详细描述

  • Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)

  • Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3

  1. If Minimal Residual Disease & qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance
  2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
  • M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
  1. If Minimal Residual Disease & qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine
  2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab
  • In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.
  • Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction

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 19 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
  • •Philadelphia chromosome-positive t(9;22)(q34;q11) or
  • •Patients with failed remission who had blast > 5% on bone marrow test after initial remission induction therapy or
  • •Hypodiploidy (Number of chromosomes < 44 (less than 44)) or
  • •E2A-HLF(Hepatic Leukemia Factor) translocation-positive or
  • •When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy

排除标准

  • •Participants with contraindications to medications
  • •When the study participant or their legal representative withdraws consent
  • •Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
  • •Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol

研究组 & 干预措施

[Arm A, Dasatinib(Sprycel) Arm]

Experimental

▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)

  • Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
  1. If MRD & qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance
  2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT
  • M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT
  1. If MRD & qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine
  2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab
  • In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.

干预措施: Dasatinib(Sprycel) arm (Drug)

[Arm B, Non-Dasatinib(Sprycel) Arm]

Experimental

▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction

  • Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
  1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT
  2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT
  • M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT
  1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine
  2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab

干预措施: Non-Dasatinib(Sprycel) arm (Drug)

结局指标

主要结局

Event free survival

时间窗: Up to 5 years

次要结局

  • Recurred rate(Up to 5 years)
  • Death rate related to infusion(Up to 5 years)
  • Adverse Event(From Day 1 of the clinical trial to 28 days after last drug administration)
  • The rate of Hematopoietic stem cell transplantation(Up to 5 years)
  • Overall survival(Up to 5 years)

研究者

发起方
Hyoung Jin Kang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hyoung Jin Kang

Professor

Seoul National University Hospital

研究点 (11)

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