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

Recruiting at 53 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Disqualifiers: Stem cell transplant, Prior cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Maria M Gramatges

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients must have a life expectancy of > 1 year

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Assessment

Participants undergo clinical assessment to determine post-treatment outcomes and chronic health conditions

Up to study completion

In-person assessments

Biospecimen Collection

Optional saliva/buccal swab and blood sample collection for biobanking and genetic analysis

Single session

Neurocognitive Assessment

Participants undergo neurocognitive assessment to evaluate neuropsychological outcomes

Up to study completion

In-person assessments

Follow-up

Participants are monitored for long-term health outcomes and quality of life

Up to study completion

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Blood collection
• Clinical Assessments
• Clinical Evaluation
• Neurological Assessments
• Questionnaire Administration
• Saliva collection
• Survey Administration

How Is the Trial Designed?

Group I: Observational (biospecimen collection, clinical evaluation) Experimental Treatment 5 Interventions

Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+