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Recruiting NCT05702645

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

Trial Parameters

Condition B Acute Lymphoblastic Leukemia Associated With Down Syndrome
Sponsor Children's Oncology Group
Study Type OBSERVATIONAL
Phase N/A
Enrollment 330
Sex ALL
Min Age 6 Years
Max Age 39 Years
Start Date 2023-11-30
Completion 2029-06-30
Interventions
Biospecimen CollectionClinical EvaluationNeurocognitive Assessment

Brief 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 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 enro

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