CompletedNot Applicable

Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

United States, Australia, Canada233 participantsStarted 2007-01

Plain-language summary

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.

Who can participate

Age range

1 Year – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in neurocognitive function by the Pediatric Quality of Life (PedQL) battery, Full Scale Intelligence Quotient (FSIQ) score

Timeframe: From baseline to up to 24 months

Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity

Timeframe: Up to 24 months

Trial details

NCT IDNCT00437060

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Childhood B Acute Lymphoblastic Leukemia trials

Who can participate

Age range

1 Year – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.