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NCT05702645Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 25 Aug 2026

Brief summary (registry, in English)

This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.

Status (registry)
Recruiting
Study type
Observational
Enrollment
330 (estimated)
First submitted
9 Jan 2023
Start date
30 Nov 2023
Primary completion date
30 Jun 2029
Lead sponsor
Children's Oncology Group
NCT number
NCT05702645

What you commit to

  • Study type: Observational
  • Planned participants: 330
  • From 30 Nov 2023 to the primary completion date, 30 Jun 2029
  • 73 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Patients whose parents or guardians are unable to complete the required forms are excluded

Who the study is looking for

  • 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

Age in the registry: 6 years to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (73)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital
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LondonCanadaRecruiting
Children's Hospital Medical Center of Akron
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AkronUnited StatesRecruiting
Albany Medical Center
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AlbanyUnited StatesRecruiting
C S Mott Children's Hospital
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Ann ArborUnited StatesRecruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
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AtlantaUnited StatesRecruiting
Augusta University Medical Center
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AugustaUnited StatesRecruiting
Dell Children's Medical Center of Central Texas
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AustinUnited StatesRecruiting
Sinai Hospital of Baltimore
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BaltimoreUnited StatesRecruiting
Children's Hospital of Alabama
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BirminghamUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesRecruiting
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesRecruiting
Cleveland Clinic Foundation
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ClevelandUnited StatesRecruiting
Rainbow Babies and Childrens Hospital
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ClevelandUnited StatesRecruiting
Prisma Health Richland Hospital
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ColumbiaUnited StatesRecruiting
Nationwide Children's Hospital
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ColumbusUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesRecruiting
Dayton Children's Hospital
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DaytonUnited StatesRecruiting
Children's Hospital of Michigan
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DetroitUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesRecruiting
Cook Children's Medical Center
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Fort WorthUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesRecruiting
BI-LO Charities Children's Cancer Center
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GreenvilleUnited StatesRecruiting
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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HollywoodUnited StatesRecruiting
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesRecruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesRecruiting
UT MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of Mississippi Medical Center
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JacksonUnited StatesRecruiting
Nemours Children's Clinic-Jacksonville
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JacksonvilleUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesRecruiting
East Tennessee Childrens Hospital
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KnoxvilleUnited StatesRecruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las VegasUnited StatesRecruiting
University Medical Center of Southern Nevada
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Las VegasUnited StatesRecruiting
Sunrise Hospital and Medical Center
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Las VegasUnited StatesRecruiting
Summerlin Hospital Medical Center
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Las VegasUnited StatesRecruiting
Valley Children's Hospital
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MaderaUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
Saint Jude Children's Research Hospital
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MemphisUnited StatesRecruiting
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesRecruiting
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesRecruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesRecruiting
Yale University
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New HavenUnited StatesRecruiting
Kaiser Permanente-Oakland
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OaklandUnited StatesRecruiting
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Children's Hospital and Medical Center of Omaha
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OmahaUnited StatesRecruiting
Nemours Children's Hospital
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OrlandoUnited StatesRecruiting
Nemours Children's Clinic - Pensacola
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PensacolaUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Phoenix Childrens Hospital
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PhoenixUnited StatesRecruiting
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Rhode Island Hospital
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ProvidenceUnited StatesRecruiting
Renown Regional Medical Center
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RenoUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesRecruiting
Rady Children's Hospital - San Diego
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San DiegoUnited StatesRecruiting
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesRecruiting
Seattle Children's Hospital
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SeattleUnited StatesRecruiting
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesRecruiting
Providence Sacred Heart Medical Center and Children's Hospital
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SpokaneUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
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TampaUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesRecruiting
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesRecruiting
Wake Forest University Health Sciences
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.