What is this study trying to find out about health after leukemia treatment in persons with Down syndrome?

This study aims to learn about long-term health effects and chronic conditions in people with Down syndrome who survived acute leukemia. Researchers want to understand risks for lasting health problems to improve care for survivors. The study is sponsored by the Children's Oncology Group and focuses on quality of life after cancer treatment.

Who may be eligible for this Down syndrome and leukemia clinical trial?

Participants must be between 6 and 39 years old with Down syndrome and have survived acute lymphoblastic or myeloid leukemia. They must have completed all cancer treatments at least 3 years ago and have no history of stem cell transplant. Both English and Spanish speakers are eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this Down syndrome clinical trial?

Study-related care, including assessments and sample collections, is provided at no cost. Personal travel or other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for visits and procedures.

Actively Recruiting

Age: 6Years - 39Years

All Genders

ID05702645

Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia The Down Syndrome Phenotyping Acute Leukemia Study in Survivors DS-PALS Survivors

Led by Children's Oncology Group · Updated on 2026-05-05

330

Participants Needed

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

Who Can Participate

Age: 6Years - 39Years

All Genders

Eligibility Criteria

You may qualify if you...

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

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