Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664131
• Other study ID #: ALLNOQ
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: September 22, 2011
• Start date: August 2005
• Est. completion date: October 2008

Study information

• Verified date: September 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 28 Years

Eligibility

Inclusion Criteria:

• Childhood ALL survivors treated on institutional protocols at

• Patient will be at least 5-years from ALL diagnosis.

• Patient will be at least one year from completion of cancer therapy.

• Absence of recurrent or secondary cancer for at least one year day of enrollment.

• Between 6-28 years of age at the time of evaluation.

• Patient's or at least one parent's English is proficient enough Questionnaire.

• Parent and the child agree to participate. Consent only from will suffice if > 18 years of age at the time of assessment.

Exclusion Criteria:

• Recurrent tumor or development of secondary cancer

• Child or parent refuses to participate

• Co-morbid pre-existing disabling neurologic disease, which in the judgment of the principal investigator may compromise clinical observations.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Neurological Examination/Questionnaires
See Detailed Description section for description of treatment plan.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors.		At lease 5 years from diagnosis and at least one year after completion of therapy.	Yes
Primary	To estimate prevalence of neurologic signs as determined by detailed neurologic examination of childhood acute lymphoblastic leukemia survivors.		At lease 5 years from diagnosis and at least one year after completion of therapy.	Yes
Secondary	To estimate prevalence of neurologic disability as determined by neurologic symptoms, signs and administered questionnaire instruments.		At lease 5 years from diagnosis and at least one year after completion of therapy.	Yes
Secondary	To explore risk factors for development of neurologic disability.		At lease 5 years from diagnosis and at least one year after completion of therapy.	No
Secondary	To assess effect of neurologic disability on quality of life.		At lease 5 years from diagnosis and at least one year after completion of therapy.	No

External Links

•   St. Jude Children's Research Hospital