Health Study After Leukemia Treatment for People With Down Syndrome

Recruiting at 68 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 trial aims to better understand the long-term health of individuals with Down syndrome after treatment for acute leukemia. Researchers seek to identify factors that might lead to chronic health issues and develop guidelines to improve quality of life. Participants will undergo various assessments, including saliva and blood collection, and complete surveys. The trial seeks survivors of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) who were treated at least three years ago and have Down syndrome.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future care guidelines for individuals with Down syndrome.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to learn more about the health of individuals with Down syndrome after they have been treated for acute leukemia. Unlike standard treatments that focus on curing leukemia itself, this study looks into the long-term health impacts on these patients. By collecting biospecimens, such as saliva and blood, and conducting clinical and neurological assessments, the trial seeks to uncover valuable insights into the unique health challenges faced by this group. The hope is to improve overall care strategies for these individuals, ensuring they receive the best possible support after their initial cancer treatment.

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+