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Not Yet Recruiting NCT05702645

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

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

Sex: All
Ages: 6 Years – 40 Years
Enrollment: 330
Sponsor: Children's Oncology Group

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 enrollmentA 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: Myeloid leukemia of Down syndrome (ML-DS) would be included under AML category above. 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 transplantPatients must have been treated for ALL or AMLNote: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here aboveAll cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollmentPatients must have a life expectancy of > 1 yearPatient 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 SpanishNote: Parents or guardians are responsible for completing all forms, even in the case of subjects that are >= 18 years oldAll patients and/or their parents or legal guardians must sign a written informed consentAll institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metExclusion Criteria:Patients with history of hematopoietic stem cell transplant (HSCT) are excludedNote: 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 satisfiedPatients with a history of prior cancers other than ALL or AML are excludedNote: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibilityFemale patients who are known to be pregnant are excludedNote: A pregnancy test is not required for female patients of childbearing potential. Pregnancy status can be established by clinical history

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05702645). StuddyBuddy aggregates publicly available trial information.