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Clinical Trials in Canada / NCT05702645
Recruiting Observational

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

NCT05702645 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2023-11-30
Last updated
2026-08-25

Condition(s) studied

B Acute Lymphoblastic Leukemia Associated With Down SyndromeDown SyndromeMyeloid Leukemia Associated With Down Syndrome

Investigational drug(s) / intervention(s)

Biospecimen CollectionClinical EvaluationNeurocognitive AssessmentQuestionnaire AdministrationSurvey Administration

Biospecimen Collection: Patients undergo saliva/buccal and blood sample collection

Clinical Evaluation: Undergo a clinical assessment

Neurocognitive Assessment: Undergo neurocognitive assessment

Questionnaire Administration: Ancillary studies

Survey Administration: Ancillary studies

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
39 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama Recruiting
Phoenix Childrens Hospital Phoenix Arizona Recruiting
Valley Children's Hospital Madera California Recruiting
UCSF Benioff Children's Hospital Oakland Oakland California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California Recruiting
Rady Children's Hospital - San Diego San Diego California Recruiting
UCSF Medical Center-Mission Bay San Francisco California Recruiting
Yale University New Haven Connecticut Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida Recruiting
Nemours Children's Hospital Orlando Florida Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia Recruiting
Augusta University Medical Center Augusta Georgia Recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii Recruiting
Lurie Children's Hospital-Chicago Chicago Illinois Recruiting
University of Chicago Comprehensive Cancer Center Chicago Illinois Recruiting
Sinai Hospital of Baltimore Baltimore Maryland Recruiting
C S Mott Children's Hospital Ann Arbor Michigan Recruiting
Children's Hospital of Michigan Detroit Michigan Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan Recruiting
Bronson Methodist Hospital Kalamazoo Michigan Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota Recruiting
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota Recruiting
University of Mississippi Medical Center Jackson Mississippi Recruiting
Children's Mercy Hospitals and Clinics Kansas City Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Children's Hospital and Medical Center of Omaha Omaha Nebraska Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
University Medical Center of Southern Nevada Las Vegas Nevada Recruiting
Sunrise Hospital and Medical Center Las Vegas Nevada Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada Recruiting
Summerlin Hospital Medical Center Las Vegas Nevada Recruiting
Renown Regional Medical Center Reno Nevada Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Albany Medical Center Albany New York Recruiting

+ 33 more sites — see the full list on the official registry below.

More Children's Oncology Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05702645 on ClinicalTrials.gov ↗ ← All trials in Canada