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
- Diseases
- Acute lymphoblastic leukaemia, Chronic myeloid leukaemia, Chronic lymphocytic leukaemia, Acute myeloid leukemia, Childhood cancers
- 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
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Lurie Children's Hospital-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Rainbow Babies and Childrens Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Children's Hospital of Michigan Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| UT MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Recruiting |
| Children's Mercy Hospitals and Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Sunrise Hospital and Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| Saint Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Children's Hospital and Medical Center of Omaha Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.