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

Launched by HYOUNG JIN KANG · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on finding new treatments for pediatric patients with very high-risk acute lymphoblastic leukemia (ALL), a type of blood cancer that can affect children and teenagers. The trial is looking for participants between the ages of 1 and 19 who have specific high-risk features, such as certain genetic changes or who haven’t responded well to initial treatments. If your child has a Philadelphia chromosome, a high number of leukemia cells in their bone marrow after treatment, or other specific high-risk markers, they may be eligible to participate.

While the trial is not yet recruiting participants, those who join can expect to receive close monitoring and care as they receive the new treatment being tested. It’s important to know that not everyone will be able to participate; for example, children who are pregnant, those who cannot take the medications for any reason, or those involved in other clinical studies may be excluded. This trial aims to improve outcomes for children facing these serious health challenges, and families will be supported through the process with detailed information and care.

Gender

ALL

Eligibility criteria

• 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