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A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
NCT05702645 · Children's Oncology Group
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)
About this study
PRIMARY OBJECTIVE:
I. To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.
SECONDARY OBJECTIVES:
I. To characterize post-treatment clinical outcomes of DS-AL by prospective, in-person assessment.
II. To determine the prevalence and severity of parent-reported adverse neuropsychological (NP) outcomes in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history.
III. To determine health-related quality of life (HRQOL) in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history.
IV. To identify clinical risk determinants of CHC, NP, and clinical outcomes in survivors of DS-AL.
V. To establish a well-annotated cohort of survivors of DS-AL and associated biobank as a resource for future investigations.
EXPLORATORY OBJECTIVES:
I. For DS-acute lymphoblastic leukemia (DS-ALL), test if structural birth defects and genetic associations with etiology extend to CHC.
II. For DS-ALL, test if telomere length determined by polygenic risk score and telomere flow-fluorescence in situ hybridization (FISH) are associated with outcomes from in-person NP assessment.
OUTLINE:
Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study.
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
Study design
Enrollment target: 330 participants
Age groups: child, adult
Timeline
Starts: 2023-11-30
Estimated completion: 2029-06-30
Last updated: 2026-02-24
Interventions
Procedure: Biospecimen CollectionOther: Clinical EvaluationOther: Neurocognitive AssessmentOther: Questionnaire AdministrationOther: Survey Administration
Primary outcomes
- • Prevalence, type, and severity of chronic health conditions (CHC) (Up to study completion)
Sponsor
Children's Oncology Group · network
Contacts & investigators
InvestigatorMaria M Gramatges · principal_investigator, Children's Oncology Group
All locations (70)
Children's Hospital of AlabamaRecruiting
Birmingham, Alabama, United States
Phoenix Childrens HospitalRecruiting
Phoenix, Arizona, United States
Valley Children's HospitalRecruiting
Madera, California, United States
UCSF Benioff Children's Hospital OaklandRecruiting
Oakland, California, United States
Kaiser Permanente-OaklandRecruiting
Oakland, California, United States
University of California Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
Rady Children's Hospital - San DiegoRecruiting
San Diego, California, United States
UCSF Medical Center-Mission BayRecruiting
San Francisco, California, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Alfred I duPont Hospital for ChildrenRecruiting
Wilmington, Delaware, United States
Golisano Children's Hospital of Southwest FloridaRecruiting
Fort Myers, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
Hollywood, Florida, United States
Nemours Children's Clinic-JacksonvilleRecruiting
Jacksonville, Florida, United States
Nemours Children's HospitalRecruiting
Orlando, Florida, United States
Nemours Children's Clinic - PensacolaRecruiting
Pensacola, Florida, United States
Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
Tampa, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank HospitalRecruiting
Atlanta, Georgia, United States
Augusta University Medical CenterRecruiting
Augusta, Georgia, United States
Kapiolani Medical Center for Women and ChildrenRecruiting
Honolulu, Hawaii, United States
Lurie Children's Hospital-ChicagoRecruiting
Chicago, Illinois, United States
Sinai Hospital of BaltimoreRecruiting
Baltimore, Maryland, United States
C S Mott Children's HospitalRecruiting
Ann Arbor, Michigan, United States
Children's Hospital of MichiganRecruiting
Detroit, Michigan, United States
Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer CenterRecruiting
Minneapolis, Minnesota, United States
University of Mississippi Medical CenterRecruiting
Jackson, Mississippi, United States
Children's Mercy Hospitals and ClinicsRecruiting
Kansas City, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Children's Hospital and Medical Center of OmahaRecruiting
Omaha, Nebraska, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
University Medical Center of Southern NevadaRecruiting
Las Vegas, Nevada, United States
Sunrise Hospital and Medical CenterRecruiting
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
Las Vegas, Nevada, United States
Summerlin Hospital Medical CenterRecruiting
Las Vegas, Nevada, United States
Renown Regional Medical CenterRecruiting
Reno, Nevada, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Albany Medical CenterRecruiting
Albany, New York, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Montefiore Medical Center - Moses CampusRecruiting
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer CenterRecruiting
Chapel Hill, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
Sanford Broadway Medical CenterRecruiting
Fargo, North Dakota, United States
Children's Hospital Medical Center of AkronRecruiting
Akron, Ohio, United States
Rainbow Babies and Childrens HospitalRecruiting
Cleveland, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Nationwide Children's HospitalRecruiting
Columbus, Ohio, United States
Dayton Children's HospitalRecruiting
Dayton, Ohio, United States
University of Oklahoma Health Sciences CenterNot Yet Recruiting
Oklahoma City, Oklahoma, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
Prisma Health Richland HospitalRecruiting
Columbia, South Carolina, United States
BI-LO Charities Children's Cancer CenterRecruiting
Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux FallsRecruiting
Sioux Falls, South Dakota, United States
East Tennessee Childrens HospitalRecruiting
Knoxville, Tennessee, United States
Saint Jude Children's Research HospitalRecruiting
Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
Dell Children's Medical Center of Central TexasRecruiting
Austin, Texas, United States
UT Southwestern/Simmons Cancer Center-DallasRecruiting
Dallas, Texas, United States
Cook Children's Medical CenterRecruiting
Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
Houston, Texas, United States
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's HospitalRecruiting
Spokane, Washington, United States
University of Wisconsin Carbone Cancer Center - University HospitalRecruiting
Madison, Wisconsin, United States
Marshfield Medical Center-MarshfieldRecruiting
Marshfield, Wisconsin, United States
Children's Hospital of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Children's HospitalRecruiting
London, Ontario, Canada