Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Neurological Examination/Questionnaires
Intervention type(s): Other
Intervention description(s): See Detailed Description section for description of treatment plan.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Survivors of ALL who are currently 6-28 years of age, 5 years from ALL diagnosis, and 1
        year off therapy who were treated on institutional protocols at St. Jude Children's
        Research Hospital. Survivors will be recruited in the Leukemia and ACT clinics at St. Jude
        Children's Research Hospital. We anticipate that 494 survivors are available. We plan to
        enroll every survivor who is eligible and visits Leukemia or/ and ACT clinic at St. Jude
        Children's Research Hospital
      
Keywords: Acute Lymphoblastic Leukemia; ALL survivors; ALL neurologic symptoms; ALL neurologic disability; ALL late effects