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Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

RECRUITINGPhase 2Sponsored by Hyoung Jin Kang
Actively Recruiting
PhasePhase 2
SponsorHyoung Jin Kang
Started2024-10-20
Est. completion2034-12-31
Eligibility
Age1 Year – 19 Years
Healthy vol.Accepted

Summary

Very high-risk acute lymphoblastic leukemia

Eligibility

Age: 1 Year – 19 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Conditions2

Acute Lymphoblastic Leukemia, PediatricCancer

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