Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome

Completed

Conditions studied: Leukemia, Down Syndrome

In brief

Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive assessment is frequently implemented during therapy and continued into survivorship to monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at 10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are comparable to or lower than patients without DS, however, these patients are at greater risk for treatment-related toxicities. Children with preexisting neurodevelopmental conditions, including DS, are systematically excluded from neurocognitive assessment on clinical trials, contributing to a gap in the investigators understanding of outcomes in these patients with preexisting neurocognitive vulnerability. The investigators propose a novel preliminary investigation of functional outcomes in children with DS and childhood leukemia. This study has implications for future treatment of leukemia patients with DS, and may generalize to leukemia patients with other predispositions or preexisting neurodevelopmental conditions (e.g., genetic disorders, acquired brain injury, autism, and epilepsy). Primary Objective: * To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down Syndrome using a novel assessment approach.

Key facts

Study ID

NCT02859389

Run by

St. Jude Children's Research Hospital

People needed

43

Starts

2016-08-18

Expected to finish

2019-01-31

Last updated by the study team

2019-09-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is an SJCRH patient with a diagnosis of leukemia.
• Diagnosis of Trisomy 21 DS as documented in the medical record
• Completed all cancer-directed therapy at SJCRH, since 1980, and at least 6 months prior to the study visit
• English as the primary language

You may not qualify if…

• Documented history of central nervous system (CNS) injury or disease that occurred after completing cancer-directed therapy
• History of or current substance use or abuse

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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