AALL06N1: A Study of Neurocognitive Function in Children Treated for ALL

Investigator: Julio Barredo

Institutional Protocol #: 20070556

National Clinical Trials Identifier: NCT00437060

Funding Agency/Sponsor: Children Oncology Group

Division: Cancer Center

Therapeutic Area: Pediatric Cancer

Phase: N/A

Enrolling Sites: Jackson Memorial Hospital

Enrolling Since: 11/30/2015


This clinical trial is looking at brain function in young patients receiving methotrexate for
acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain
function may help doctors plan cancer treatment.

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

Gender: All

Minimum Age: 1 Year

Maximum Age: 17 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Cancer Center Studies


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