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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT02339350
Eligibility Criteria:
Inclusion Criteria:
1\. Diagnosis
1. Newly diagnosed B-precursor ALL meeting criteria 1.2
2. Newly diagnosed B-precursor ALL who was previously treated with steroid.
3. Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia
1.2 Initial WBC count
1. from 1 years old to 9 years old : WBC ≥ 50,000/μL
2. from 10 years old to 21 years old : Any WBC
3. from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3)
Exclusion Criteria:
1. Philadelphia chromosome (+) or bcr/abl rearrangement (+)
2. Chromosome \<45 by cytogenetics
3. Induction failure (Day 28 M3 marrow (\>25% blasts))
4. t(4:11) (as identified by cytogenetics, FISH or molecular studies)
5. Early T-cell precursor leukemia
6. Down syndrome ALL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT02339350
Study Brief:
Protocol Section:
NCT02339350