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

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 threerecognized types: trisomy 21 resulting from chromosomal nondisjunction (mostcommon), translocation (the patient has 46 chromosomes, but all or part of anadditional 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 acutemyeloid leukemia [AML])

• Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AMLcategory 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 thepatient otherwise meets eligibility criteria, i.e., treatment for relapse wascompleted at least 36 calendar months prior to enrollment and did not includestem cell transplant

• Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known astransient myeloproliferative disease (TMD), is not alone sufficient forinclusion in this study

• Patients must have been treated for ALL or AML

• Note: History of COG therapeutic trial participation is not required. As areminder ML-DS would be included under the AML category here above

• All cancer treatment (oral or intravenous) must have been completed at least 36calendar 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 leastone 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 informedconsent

• 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 allother 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 AMLdiagnosis are also excluded

• Note: Prior history of transient abnormal myelopoiesis is allowed, but is notsufficient for eligibility

• Patients whose parents or guardians are unable to complete the required forms areexcluded