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

RecruitingObservational study

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

Who can join

Ages 6 to 39 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Children's Oncology Group · Participants: 330 · Started: Nov 30, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05702645

Locations in the U.S.

AlabamaChildren's Hospital of Alabama, Birmingham
ArizonaPhoenix Childrens Hospital, Phoenix
CaliforniaValley Children's Hospital, Madera
Kaiser Permanente-Oakland, Oakland
UCSF Benioff Children's Hospital Oakland, Oakland
University of California Davis Comprehensive Cancer Center, Sacramento
Rady Children's Hospital - San Diego, San Diego
UCSF Medical Center-Mission Bay, San Francisco
ConnecticutYale University, New Haven
DelawareAlfred I duPont Hospital for Children, Wilmington
FloridaGolisano Children's Hospital of Southwest Florida, Fort Myers
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood
Nemours Children's Clinic-Jacksonville, Jacksonville
Nemours Children's Hospital, Orlando
Nemours Children's Clinic - Pensacola, Pensacola
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa
GeorgiaChildren's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta
Augusta University Medical Center, Augusta
HawaiiKapiolani Medical Center for Women and Children, Honolulu
IllinoisLurie Children's Hospital-Chicago, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
MarylandSinai Hospital of Baltimore, Baltimore
MichiganC S Mott Children's Hospital, Ann Arbor
Children's Hospital of Michigan, Detroit
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Bronson Methodist Hospital, Kalamazoo
MinnesotaChildren's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis
University of Minnesota/Masonic Cancer Center, Minneapolis
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriChildren's Mercy Hospitals and Clinics, Kansas City
Washington University School of Medicine, St Louis
NebraskaChildren's Hospital and Medical Center of Omaha, Omaha
University of Nebraska Medical Center, Omaha
NevadaAlliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas
Summerlin Hospital Medical Center, Las Vegas
Sunrise Hospital and Medical Center, Las Vegas
University Medical Center of Southern Nevada, Las Vegas
Renown Regional Medical Center, Reno
New JerseyHackensack University Medical Center, Hackensack
New YorkAlbany Medical Center, Albany
Roswell Park Cancer Institute, Buffalo
Montefiore Medical Center - Moses Campus, The Bronx
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
Wake Forest University Health Sciences, Winston-Salem
North DakotaSanford Broadway Medical Center, Fargo
OhioChildren's Hospital Medical Center of Akron, Akron
Cleveland Clinic Foundation, Cleveland
Rainbow Babies and Childrens Hospital, Cleveland
Nationwide Children's Hospital, Columbus
Dayton Children's Hospital, Dayton
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonOregon Health and Science University, Portland
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
Rhode IslandRhode Island Hospital, Providence
South CarolinaPrisma Health Richland Hospital, Columbia
BI-LO Charities Children's Cancer Center, Greenville
South DakotaSanford USD Medical Center - Sioux Falls, Sioux Falls
TennesseeEast Tennessee Childrens Hospital, Knoxville
Saint Jude Children's Research Hospital, Memphis
Vanderbilt University/Ingram Cancer Center, Nashville
TexasDell Children's Medical Center of Central Texas, Austin
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
Cook Children's Medical Center, Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston
UT MD Anderson Cancer Center, Houston
University of Texas Health Science Center at San Antonio, San Antonio
WashingtonSeattle Children's Hospital, Seattle
Providence Sacred Heart Medical Center and Children's Hospital, Spokane
WisconsinUniversity of Wisconsin Carbone Cancer Center - University Hospital, Madison
Marshfield Medical Center-Marshfield, Marshfield
Children's Hospital of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.