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Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors

8 Years
Open (Enrolling)
Neurocognitive Impairment, Acute Lymphoblastic Leukemia

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Trial Information

Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors

Survival rates for pediatric acute lymphoblastic leukemia (ALL) now exceed 80%. With this
growing population of long-term survivors comes recognition that a considerable proportion
experience one or more significant late effects. For children undergoing central nervous
system (CNS) treatment, common late effects include neurocognitive impairment and
neurobehavioral problems. Although these problems first manifest as subtle difficulties with
attention and processing speed, they can evolve into deficits in higher order brain
functions that significantly impact functional skills in a subset of long-term survivors.
There currently is no method to accurately identify patients at greatest risk for these
long-term behavioral and neurocognitive problems. Through this proposal, this study plans
to utilize existing data collected during acute treatment to identify predictors of
long-term neurocognitive and brain maturation outcomes. The study also proposes to collect
data on attention-deficit/hyperactivity disorder (ADHD) and associated comorbidities, higher
order executive functions, and structural and functional brain imaging in survivors who are
at least 8 years of age and greater than 5 years from diagnosis.

All patients will undergo a single neurocognitive evaluation focused on assessment of higher
order executive functions. Patients will be evaluated during their regularly scheduled
annual follow-up visit, when health-related monitoring will also occur. Parents of
participants will be asked to complete questionnaires designed to assess the family
environment and the impact of cancer diagnosis on family functioning and parent stress.

Brain Imaging: To better demonstrate untoward treatment effects upon cortical brain
development, quantitative MR imaging of myelin integrity using diffusion tensor imaging
(DTI) and cortical thickness assessment using high resolution volumetric imaging will be
utilized. All patients will also be evaluated using functional MRI procedures during resting
state and participation in attention and working memory tasks.

Inclusion Criteria:

- Enrolled on SJCRH TOTXV ALL protocol

- ≥ 5 years post diagnosis of ALL

- ≥ 8.0 years of age at time of follow-up evaluation

Exclusion Criteria:

- History of cranial or total-body radiation therapy

- History of bone marrow transplant

- History of relapse

- History of head injury, neurological condition unrelated to ALL treatment, or
diagnosis of a genetic disorder associated with neurocognitive impairment (e.g. Down

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Neurocognitive assessment of attention, processing speed, and executive functions.

Outcome Time Frame:

Once, at least 5 years post ALL diagnosis and 2 years off treatment

Safety Issue:


Principal Investigator

Kevin Krull, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

June 2015

Related Keywords:

  • Neurocognitive Impairment
  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Neurocognitive function
  • ADHD
  • brain imaging
  • genetic polymorphisms
  • Psychopathology and neurocognitive Impairment in Leukemia Survivors
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794