Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors
Treatment of acute lymphoblastic leukemia achieves high cure rate, but is potentially
neurotoxic.
Long-term neurologic morbidity in survivors and its effect on function are inadequately
studied.
Neurologic outcomes will be assessed through an investigator administered questionnaire
followed by comprehensive neurologic examination by the study neurologist.
Acute lymphoblastic leukemia (ALL) is the most prevalent childhood malignant disease.
Survival has improved from 5-10% in the early 1960s to over 80% at present. Historically,
the central nervous system (CNS) was the most common site of leukemia relapse. However,
major improvement in cure rates was achieved with the addition of CNS directed therapy using
initially craniospinal irradiation, and more recently, a combination of high-dose systemic
methotrexate and intrathecal chemotherapy.
ALL mostly afflicts children in the first 12-years of life, an age when progressive
myelination is taking place and the central nervous system is more vulnerable to chemical
and radiologic injury. Many ALL studies have reported neurologic adverse events related to
the treatment.
Little is known about the long-term outcome of neurologic toxicity developing during
treatment of leukemia, or development of new late onset neurologic complications. No data is
available about outcomes of non-behavioral/cognitive neurologic complications, such as
seizures, incoordination, headache, loss of motor or sensory function, impaired energy and
muscle weakness. In addition, there is no data available on impact of neurologic disability
on quality of life of ALL survivors.
It is important to understand and recognize neurologic disability, its causes and impact on
function and quality of life so that adequate and timely remedies can be offered through
education and appropriate interventions can be undertaken to help prevent long-term
morbidity.
This is a prospective observational study of ALL St. Jude Children's Research Hospital
survivors to determine the prevalence of different headache syndromes, as defined by
International Society of Headache criteria (IHS) and the prevalence and severity of seizures
and their relationship to leukemia treatment. We will establish incidence, type, severity,
and disability of sensory-motor neuropathy when present or any long term progression of
initial peripheral nerve injury in ALL survivors. This study will also help define whether
there is a higher incidence of low back pain and if there is any relation to a specific
treatment.
Subjects will have a one-time evaluation with an investigator administered questionnaire and
a neurologic examination.
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