DSCOG: Learning, Behavior and Social Skills in Survivors of Childhood Leukemia with Down syndrome

Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia with Down syndrome

Category:

Leukemia / Lymphoma

Diseases Treated:

Leukemia

Eligibility Overview:

This is a non-therapeutic clinical trial that is open only to patients who were treated at St. Jude Children’s Research Hospital since 1980 and are currently followed at the hospital.

  • St. Jude Children’s Research Hospital patient with acute leukemia (i.e., ALL or AML)
  • Trisomy 21 Down syndrome diagnosis
  • Completed all cancer therapy at St. Jude since 1980 and at least six months prior to study visit
  • English as the primary language
  1. Brief Summary

    Studies have shown that children with Down syndrome have a 10 to 20-fold increased risk for leukemia and have a greater risk for treatment-related toxicities. While all childhood leukemia survivors are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes and lower quality of life, survivors with Down syndrome may face additional challenges.

    Children with preexisting neurodevelopmental conditions, including Down syndrome, are systematically excluded from neurocognitive assessment on clinical trials, contributing to a gap in our understanding of outcomes in these patients with preexisting neurocognitive vulnerability. This study will conduct a preliminary investigation of functional outcomes in children with Down syndrome and childhood leukemia. The trial has implications for future treatment of leukemia patients with Down syndrome 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.  

    Eligibility Criteria

    Inclusion criteria include:

    • St. Jude Children’s Research Hospital patient with acute leukemia (i.e., ALL or AML)
    • Trisomy 21 Down syndrome diagnosis
    • Completed all cancer-directed therapy at St. Jude since 1980 and at least six months prior to study visit
    • English as the primary language

    Exclusion Criteria include:

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

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    Leukemia is a cancer of the blood cells. It is the most common childhood cancer. Treatment may include radiation and strong cancer medicine, also known as chemotherapy. These treatments can sometimes cause children to develop problems with learning, behavior and social skills later in life.

    Down syndrome is a condition that is caused by changes in the body’s genes. Children with Down syndrome can have a harder time learning. They also have a higher risk of developing leukemia.

    This study will focus on childhood leukemia survivors with Down syndrome. Researchers will ask survivors to take a test to see what kinds of learning, behavior and social problems they may have. Researchers will also ask parents questions about their children’s learning and behavior. The study will take about two hours for survivors and their parents to complete. Researchers hope the study will help other children with leukemia and Down syndrome in the future.

    Purpose of this clinical trial

    The main goal of this study is to learn about thinking, learning, behavior and social functioning in childhood leukemia survivors with Down syndrome.

    Eligibility overview

    • St. Jude Children’s Research Hospital patient with acute leukemia (i.e., ALL or AML)
    • Trisomy 21 Down syndrome diagnosis
    • Completed all cancer therapy at St. Jude since 1980 and at least six months prior to study visit
    • English as the primary language
  3. DSCOP Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT02859389
    Trial start date August 2016
    Estimate enrollment 80
    Study type Observational
    Conditions Leukemia with Down syndrome
    Ages

    All

    Principal investigator Lisa Jacola, PhD
    Study sites St. Jude Children’s Research Hospital 
    For a consultation or to discuss DSCOG St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Lisa Jacola, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.