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New study aims to uncover hidden health risks in down syndrome leukemia survivors

NCT ID NCT05702645

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study looks at the long-term health of people with Down syndrome who have been treated for acute leukemia. Researchers want to understand what chronic health problems survivors may face and what factors contribute to them. The goal is to create better follow-up care guidelines to improve quality of life. The study will enroll 330 survivors aged 6 to 39.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

DS-AL survivors from the Children's Oncology Group (COG) Registry and Epidemiology protocols or locally from participating institutions.

Ages

6 to 39 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    73 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Alfred I duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    RECRUITING

    Las Vegas, Nevada, 89135, United States

    Contact Email: •••••@•••••

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • BI-LO Charities Children's Cancer Center

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Bronson Methodist Hospital

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

  • C S Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital and Medical Center of Omaha

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

    Contact Email: •••••@•••••

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact Email: •••••@•••••

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • East Tennessee Childrens Hospital

    RECRUITING

    Knoxville, Tennessee, 37916, United States

  • Golisano Children's Hospital of Southwest Florida

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Kapiolani Medical Center for Women and Children

    RECRUITING

    Honolulu, Hawaii, 96826, United States

  • Lurie Children's Hospital-Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

    Contact Email: •••••@•••••

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    RECRUITING

    Orlando, Florida, 32827, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Phoenix Childrens Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Prisma Health Richland Hospital

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Providence Sacred Heart Medical Center and Children's Hospital

    RECRUITING

    Spokane, Washington, 99204, United States

  • Rady Children's Hospital - San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • Rainbow Babies and Childrens Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    RECRUITING

    Tampa, Florida, 33607, United States

  • Saint Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57117-5134, United States

    Contact Email: •••••@•••••

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sinai Hospital of Baltimore

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • Summerlin Hospital Medical Center

    RECRUITING

    Las Vegas, Nevada, 89144, United States

    Contact Email: •••••@•••••

  • Sunrise Hospital and Medical Center

    RECRUITING

    Las Vegas, Nevada, 89109, United States

    Contact Email: •••••@•••••

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • UCSF Medical Center-Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University Medical Center of Southern Nevada

    RECRUITING

    Las Vegas, Nevada, 89102, United States

    Contact Email: •••••@•••••

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Minnesota/Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Valley Children's Hospital

    RECRUITING

    Madera, California, 93636, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

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