Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06257394
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
19 Years
Study:
NCT06257394
Study Brief:
Protocol Section:
NCT06257394