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Understanding the health of individuals with Down syndrome after leukemia treatment

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

Observational Children's Oncology Group · NCT05702645

This study looks at the long-term health and quality of life of people with Down syndrome who have survived leukemia to see how it affects them compared to those who haven't had cancer.

Quick facts

Study typeObservational
Enrollment330 (estimated)
Ages6 Years to 39 Years
SexAll
SponsorChildren's Oncology Group Research network
Drugs / interventionsCAR T, chimeric antigen receptor
Locations70 sites (Birmingham, Alabama and 69 other locations)
Trial IDNCT05702645 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the long-term health outcomes of individuals with Down syndrome who have survived acute leukemia. It focuses on assessing the prevalence and severity of chronic health conditions, neuropsychological outcomes, and overall quality of life in these survivors compared to individuals with Down syndrome who have not had cancer. The study involves clinical evaluations, biospecimen collection, and parent-reported assessments to gather comprehensive data. The findings will help develop clinical guidelines for survivorship care to enhance the quality of life for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 6 to 40 years with a diagnosis of Down syndrome who are survivors of acute lymphoblastic leukemia or acute myeloid leukemia.

Not a fit: Patients who do not have Down syndrome or have not survived acute leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved care strategies and quality of life for individuals with Down syndrome who have survived leukemia.

How similar studies have performed: While there have been studies focusing on leukemia outcomes, this specific approach to understanding long-term health in Down syndrome survivors is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients age \>= 6 and \< 40 years at the time of enrollment
* A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells)
* All patients must be DS-AL survivors (acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\])

  * Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant
  * Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study
* Patients must have been treated for ALL or AML

  * Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above
* All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment
* Patients must have a life expectancy of \> 1 year
* Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish

  * Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are \>= 18 years old
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Patients with history of hematopoietic stem cell transplant (HSCT) are excluded

  * Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied
* Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded

  * Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility
* Patients whose parents or guardians are unable to complete the required forms are excluded

Where this trial is running

Birmingham, Alabama and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B Acute Lymphoblastic Leukemia Associated With Down SyndromeDown SyndromeMyeloid Leukemia Associated With Down Syndrome
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.