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

Launched by CHILDREN'S ONCOLOGY GROUP · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to understand the long-term health of individuals with Down syndrome who have been treated for acute leukemia, a type of blood cancer. Researchers want to find out more about the possible long-lasting effects of cancer treatment on these patients, as they may experience different side effects compared to others. The information gathered will help create better care guidelines for survivors, aiming to improve their quality of life.

To participate in the study, individuals must be between 6 and 40 years old, have a diagnosis of Down syndrome, and be survivors of either acute lymphoblastic leukemia or acute myeloid leukemia. Participants need to have completed their cancer treatment at least three years before joining the study. The trial welcomes both English and Spanish speakers, and it’s important that parents or guardians can help with the required paperwork. Overall, this study is a valuable opportunity to contribute to our understanding of health challenges faced by people with Down syndrome after cancer treatment.

Gender

ALL

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 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