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

Recruiting now

Conditions studied: B Acute Lymphoblastic Leukemia Associated With Down Syndrome, Down Syndrome, Myeloid Leukemia Associated With Down Syndrome

In brief

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.

Key facts

Study ID

NCT05702645

Run by

Children's Oncology Group

People needed

330

Starts

2023-11-30

Expected to finish

2029-06-30

Last updated by the study team

2026-05-05

Who can join

Age: 6 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States (enrolling)
• Valley Children's Hospital — Madera, California, United States (enrolling)
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
• Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Rady Children's Hospital - San Diego — San Diego, California, United States (enrolling)
• UCSF Medical Center-Mission Bay — San Francisco, California, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (enrolling)
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States (enrolling)
• Nemours Children's Hospital — Orlando, Florida, United States (enrolling)
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States (enrolling)
• Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States (enrolling)
• Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States (enrolling)
• Augusta University Medical Center — Augusta, Georgia, United States (enrolling)
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (enrolling)
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States (enrolling)
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Children's Hospital of Michigan — Detroit, Michigan, United States (enrolling)
• Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)
• Children's Hospital of Alabama — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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