Acute Lymphoblastic LeukemiaNCT00664131
Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors
An observational study of Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 28 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Neurological Examination/Questionnaires
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Neurological Examination/Questionnaires
- Keywords
- Acute Lymphoblastic Leukemia, ALL survivors, ALL neurologic symptoms, ALL neurologic disability, ALL late effects
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological Examination/QuestionnairesOther
See Detailed Description section for description of treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Neurological Examination/Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors.
Measured: At lease 5 years from diagnosis and at least one year after completion of therapy.
To estimate prevalence of neurologic signs as determined by detailed neurologic examination of childhood acute lymphoblastic leukemia survivors.
Measured: At lease 5 years from diagnosis and at least one year after completion of therapy.
Secondary outcomes (3)
To estimate prevalence of neurologic disability as determined by neurologic symptoms, signs and administered questionnaire instruments.
Measured: At lease 5 years from diagnosis and at least one year after completion of therapy.
To explore risk factors for development of neurologic disability.
Measured: At lease 5 years from diagnosis and at least one year after completion of therapy.
To assess effect of neurologic disability on quality of life.
Measured: At lease 5 years from diagnosis and at least one year after completion of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startAug 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Ness, PT, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664131
- Sponsor's protocol ID
- ALLNOQ
- Status last verified
- Sep 2011
- First submitted
- 21 Apr 2008
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors
- ClinicalTrials.gov ID
- NCT00664131
- Acronym / sponsor ID
- ALLNOQ
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, ALL survivors, ALL neurologic symptoms, ALL neurologic disability, ALL late effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Neurological Examination/Questionnaires |
Who may qualify
- Ages
- 6 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological Examination/QuestionnairesSee Detailed Description section for description of treatment plan. | Other | 1 |
Primary outcome
To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors.
Time frame: At lease 5 years from diagnosis and at least one year after completion of therapy.
To estimate prevalence of neurologic signs as determined by detailed neurologic examination of childhood acute lymphoblastic leukemia survivors.
Time frame: At lease 5 years from diagnosis and at least one year after completion of therapy.
3 secondary outcomes
To estimate prevalence of neurologic disability as determined by neurologic symptoms, signs and administered questionnaire instruments.
Time frame: At lease 5 years from diagnosis and at least one year after completion of therapy.
To explore risk factors for development of neurologic disability.
Time frame: At lease 5 years from diagnosis and at least one year after completion of therapy.
To assess effect of neurologic disability on quality of life.
Time frame: At lease 5 years from diagnosis and at least one year after completion of therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Ness, PT, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors. (time frame: At lease 5 years from diagnosis and at least one year after completion of therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2011.