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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00437060
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute lymphoblastic leukemia
* Enrolled on COG-AALL0434 (Cohort #1 only) or COG-AALL0232 (Cohorts #1 and #2)
* Patients must have received either high-dose methotrexate or escalating-dose methotrexate during interim maintenance.
* No CNS-3 disease
* Patients must enroll within 8-24 months after completion of therapy on COG-AALL0232 and no evidence of relapsed or secondary malignancy
* No known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following:
* Down syndrome
* Fragile X mental retardation
* Autism
* Pervasive developmental disability
* Seizure disorder
* Attention-deficit hyperactivity disorder or specific learning disability (e.g., dyslexia) allowed
* No sensory impairment (e.g., pre-existing uncorrectable vision impairment or deafness)
* No cranial radiation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT00437060
Study Brief:
Protocol Section:
NCT00437060