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Understanding Health After Leukemia Treatment in People with Down Syndrome

This observational study aims to understand the long-term health of people with Down syndrome after they have been treated for acute leukemia. Researchers want to learn more about common health problems (chronic health conditions) and other long-term effects that may happen after cancer treatment. By collecting information through clinical evaluations, neurocognitive assessments, questionnaires, and surveys, the study hopes to identify factors that contribute to these conditions. This information will help develop better care guidelines to improve the quality of life for survivors. You may be able to join if you are 6 to 39 years old, have Down syndrome, and have been treated for B Acute Lymphoblastic Leukemia or Myeloid Leukemia associated with Down Syndrome. The study is looking for 330 participants.

Study design
This is an observational study, meaning researchers will collect information without providing new treatments. It plans to enroll 330 participants.
What's involved
You would provide saliva/buccal and blood samples, undergo a clinical assessment, and complete neurocognitive assessments, questionnaires, and surveys.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which measures chronic health conditions, will be assessed up to study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05702645

A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia

Recruiting
Not specifiedAges 6–39Observational
Children's Oncology Group
~330 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Biospecimen CollectionClinical EvaluationNeurocognitive AssessmentQuestionnaire AdministrationSurvey Administration

At a glance

Recruiting sites
73 of 73 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence, type, and severity of chronic health conditions (CHC)
Measured over Up to study completion

Conditions

B Acute Lymphoblastic Leukemia Associated With Down Syndrome
Down Syndrome
Myeloid Leukemia Associated With Down Syndrome

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaDown Syndrome

Where it's being run

73 sites across 32 states
California6
Florida6
Texas6
Nevada5
Ohio5
Michigan4
New York3
Tennessee3

Study leadership

  • Maria M Gramatges · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Prevalence, type, and severity of chronic health conditions (CHC)Up to study completion

    Summary statistics will be used to characterize the study populations on CHC outcomes. Quantitative data (number of comorbidities) will be summarized using descriptive statistics and correlational techniques. Will use pooled logistic regression to estimate overall response, 95% confidence interval (CI), and p-values for association of acute leukemia (AL) diagnosis with medical record-verified CHC, agnostic of time to CHC. Will use stratified Cox models to refine associations of AL diagnosis with CHC based on time to CHC incidence. Within each age interval, will estimate the hazard ratio, 95% CI, and p-values to report time-dependent effects of AL diagnosis on CHC.