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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00437060




Registration number
NCT00437060
Ethics application status
Date submitted
15/02/2007
Date registered
19/02/2007
Date last updated
21/07/2017

Titles & IDs
Public title
Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
Scientific title
A Study of Neurocognitive Function in Children Treated for ALL
Secondary ID [1] 0 0
NCI-2009-00315
Secondary ID [2] 0 0
AALL06N1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood B Acute Lymphoblastic Leukemia 0 0
Childhood T Acute Lymphoblastic Leukemia 0 0
Cognitive Side Effects of Cancer Therapy 0 0
Long-Term Effects Secondary to Cancer Therapy in Children 0 0
Neurotoxicity Syndrome 0 0
Psychological Impact of Cancer 0 0
Untreated Childhood Acute Lymphoblastic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Poisoning

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Cognitive Assessment
Treatment: Surgery - Diffusion Tensor Imaging
Other interventions - Laboratory Biomarker Analysis
Other interventions - Pharmacological Study
Treatment: Surgery - Psychosocial Assessment and Care

Ancillary/Correlative (neurocognitive assessment, biomarkers)) - 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.


Treatment: Surgery: Cognitive Assessment
Ancillary studies

Treatment: Surgery: Diffusion Tensor Imaging
Correlative studies

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Other interventions: Pharmacological Study
Correlative studies

Treatment: Surgery: Psychosocial Assessment and Care
Ancillary studies
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in neurocognitive function by the Pediatric Quality of Life (PedQL) battery, Full Scale Intelligence Quotient (FSIQ) score
Timepoint [1] 0 0
From baseline to up to 24 months
Primary outcome [2] 0 0
Polymorphisms as predictors of neurocognitive dysfunction or acute neurotoxicity
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Correlation between neuropsychological outcomes and acute neurotoxicity
Timepoint [1] 0 0
Up to 24 months

Eligibility
Key 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
Minimum age
1 Year
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
233
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Saskatchewan
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New Zealand
State/province [43] 0 0
Auckland
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New Zealand
State/province [44] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00437060
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Naomi Winick
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00437060