Health Outcomes in Survivors of Down Syndrome-Associated Acute Leukemia
A Study on Chronic Conditions, Neuropsychological Effects, and Quality of Life
Led by Children's Oncology Group · Updated on 2026-05-05
330
Participants Needed
70
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the health of people with Down syndrome who have been treated for acute leukemia. Children with Down syndrome face higher risks of side effects during leukemia treatment, but its unclear how this affects their long-term health. The study aims to understand chronic health conditions and other lasting effects after leukemia treatment in this group to help improve their quality of life and develop better care guidelines.
Participants may provide saliva or buccal swab samples, undergo clinical assessments, and, if they have Down syndrome-associated acute lymphoblastic leukemia, may also give blood samples and complete neurocognitive tests. These evaluations are done in parts, including biospecimen collection, clinical evaluation, and neurocognitive assessment.
During the study, participants will be assessed for chronic health conditions, neuropsychological outcomes reported by parents, health-related quality of life, and clinical risk factors. Researchers will also create a detailed group of survivors and a biobank for future research. The main outcome measured is the prevalence, type, and severity of chronic health conditions. The study will continue until June 2029, with ongoing assessments and data collection.
CONDITIONS
Brief Title
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
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Patients aged 6 to less than 40 years at enrollment
Diagnosis of Down syndrome including trisomy 21 by nondisjunction, translocation, or mosaicism
Survivors of Down syndrome-associated acute lymphoblastic leukemia or acute myeloid leukemia
Completed all cancer treatments at least 36 months before enrollment
Life expectancy greater than 1 year
Patient and parent/guardian speak and read English or Spanish
Written informed consent obtained
Compliance with institutional, FDA, and NCI human study requirements
You will not qualify if you...
History of hematopoietic stem cell transplant
History of cancers prior to leukemia diagnosis or subsequent malignant neoplasm after leukemia
Unable of parent or guardian to complete required forms
Diagnosis of transient abnormal myelopoiesis alone is not sufficient for inclusion
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Clinical Evaluation
Duration - Up to study completion
Participants undergo a clinical assessment to evaluate health status and post-treatment outcomes.
1 or more visits depending on assessments
Biospecimen Collection
Duration - Up to study completion
Participants may provide saliva/buccal swab and blood samples for research purposes.
1 or more visits depending on sample collection
Neurocognitive Assessment
Duration - Up to study completion
Participants with Down syndrome-associated acute lymphoblastic leukemia may undergo neurocognitive testing to assess neuropsychological outcomes.
1 or more visits for neurocognitive testing
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
A multicenter observational cohort study in survivors of Down Syndrome-associated acute leukemia (ALTE22C1): a report from the Children's Oncology Group.
M Monica Gramatges, Lauren N Sanclemente, Lacey Hall...