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:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06099366
Eligibility Criteria:
\<Inclusion Criteria\>
* Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
1. 1 year old ≤ Age \< 10 years old
2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
3. No testis involvement
4. Satisfaction of following organ functions
A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:
1 to \< 2 years: Male: 0.6 / Female: 0.6, 2 to \< 6 years: Male: 0.8 / Female: 0.8, 6 to \< 10 years: Male: 1 / Female: 1, 10 to \< 13 years: Male: 1.2 / Female: 1.2, 13 to \< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.
B. Liver function i. Direct bilirubin \< 3.0mg/dL
\<Exclusion Criteria\>
1. Steroid administration within 2 weeks before the registration
2. t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF
3. Newly diagnosed T cell ALL
4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
5. Burkitt leukemia/lymphoma
6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
9 Years
Study:
NCT06099366
Study Brief:
Protocol Section:
NCT06099366