Clinical trial · Observational
Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
A Study of Neurocognitive Function in Children Treated for ALL
NCT00437060CI-TRIAL-00028739completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood B Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Childhood T Acute Lymphoblastic Leukemia | Childhood T Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Cognitive Side Effects of Cancer Therapy | — | UNRESOLVED | — |
| Long-Term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
| Neurotoxicity Syndrome | — | UNRESOLVED | — |
| Psychological Impact of Cancer | — | UNRESOLVED | — |
| Untreated Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Assessment | Procedure | — | UNRESOLVED |
| Diffusion Tensor Imaging | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Psychosocial Assessment and Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary/Correlative (neurocognitive assessment, biomarkers))
- description
- Patients complete neurocognitive tests to assess thinking, memory, attention, and concentration. The baseline test is administered during the consolidation phase of chemotherapy and further tests are done at 1 year from baseline and 1 year after\* the completion of study therapy. Patients undergo blood and cerebrospinal fluid collection periodically for biomarker, genotypic polymorphisms, and pharmacokinetic analysis. Patients undergo MRI diffusion-tensor imaging to correlate imaging with neuropsychological outcomes.
- interventionNames
- Procedure: Cognitive Assessment
- Procedure: Diffusion Tensor Imaging
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Procedure: Psychosocial Assessment and Care
Primary outcomes (2)
- measure
- 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
- description
- Vocabulary and Block Design, subtests of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III), Wechsler Children Intelligence Scale (WISC-IV) and Wechsler Adult Intelligence Scale (WAIS-III) (based on age) will be used to estimate FSIQ, using the tables provided by Sattler.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.