An observational study in Childhood B Acute Lymphoblastic Leukemia, Childhood T Acute Lymphoblastic Leukemia and Cognitive Side Effects of Cancer Therapy, sponsored by Children's Oncology Group. Completed at 112 sites in 4 countries. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Children's Oncology Group · Observational
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.
OBJECTIVES:
I. Determine the neuropsychological function in children with acute lymphoblastic leukemia treated with either high-dose methotrexate or escalating-dose methotrexate in the absence of cranial radiation and nelarabine.
II. Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.
III. Correlate neuropsychological outcome measures and the occurrence of acute neurotoxicity with host polymorphisms in these patients.
IV. Measure concentrations of 5-methyltetrahydrofolate, homocysteine, Ado, S-adenosylmethionine, S-adenosylhomocysteine, and other potentially relevant compounds in serum and cerebrospinal fluid during interim maintenance therapy with low- or high-dose methotrexate regimens, respectively, and correlate these endpoints with the occurrence of acute neurologic toxicity and long-term neurocognitive dysfunction in these patients.
V. Determine whether or not diffusion tensor imaging will identify areas of selective vulnerability in CNS and provide an imaging modality that predicts and/or correlates with neuropsychological outcome.
OUTLINE: This is a prospective, cohort, multicenter study.
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.
NOTE: * Within 8 months to 24 months after the completion of study therapy for patients on AALL0232.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 233 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with newly diagnosed acute lymphoblastic leukemia meeting other criteria.
Inclusion Criteria:
Enrolled on COG-AALL0434 (Cohort #1 only) or COG-AALL0232 (Cohorts #1 and #2)
No known significant neurodevelopmental disability unrelated to cancer diagnosis including, but not limited to, any of the following:
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.
Procedure: Cognitive Assessment · Procedure: Diffusion Tensor Imaging · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Procedure: Psychosocial Assessment and Care
Ancillary studies
Correlative studies
Also known as: DTI
Correlative studies
Correlative studies
Ancillary studies
Also known as: Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies, Psychosocial Support
Change in neurocognitive function by the Pediatric Quality of Life (PedQL) battery, Full Scale Intelligence Quotient (FSIQ) score
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.
Time frame: From baseline to up to 24 months
Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity
Time frame: Up to 24 months
Correlation between neuropsychological outcomes and acute neurotoxicity
Time frame: Up to 24 months
Showing the first 100 of 112 sites across 4 countries.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group