Understanding the health of individuals with Down syndrome after leukemia treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• Phoenix Childrens Hospital
  Phoenix, Arizona, United States Recruiting
• Valley Children's Hospital
  Madera, California, United States Recruiting
• UCSF Benioff Children's Hospital Oakland
  Oakland, California, United States Recruiting
• Kaiser Permanente-Oakland
  Oakland, California, United States Recruiting
• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Maria M Gramatges — Children's Oncology Group

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• JAK inhibitor treatment for Down syndrome in children and young adults

  This study tests whether 6 months of tofacitinib can help improve safety and neurodevelopment in people with Down syndrome aged 6 to 22, compared with placebo.

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• Jump rope to improve navicular drop and foot posture in children with Down syndrome

  This project will test whether adding jump-rope exercises to play activities helps improve foot posture in 4–15-year-old children with Down syndrome who have navicular drop.

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• Thymus removal and immune aging in people with Down syndrome

  This study will try to see if removing part of the thymus affects immune health over time in people aged 1 and older with Down syndrome, comparing those who had thymectomy to those who did not and to unaffected household relatives.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07416201

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.