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A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
Las Vegas, NV
N/A
Recruiting
Led By Maria M Gramatges
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study completion
Awards & highlights
No Placebo-Only Group
Summary
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.
See full description
Eligible Conditions
- Down Syndrome
- B Acute Lymphoblastic Leukemia
- Megakaryoblastic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study completion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevalence, type, and severity of chronic health conditions (CHC)
Secondary study objectives
Clinical risk determinants of CHC, NP, and clinical outcomes
Health-related quality of life (HRQOL)
Post-treatment clinical outcomes
+2 moreOther study objectives
Structural birth defects and genetic associations with etiology extending to CHC for Down syndrome acute lymphoblastic leukemia (DS-ALL)
Telomere length (TL) determined by polygenic risk score and telomere flow-fluorescence in situ hybridization (FISH) in association with outcomes from in-person NP assessment for DS-ALL
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Observational (biospecimen collection, clinical evaluation)Experimental Treatment4 Interventions
Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients may then undergo blood sample collection in part 3 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~1810
Find a Location
Closest Location:Washington University School of Medicine· Saint Louis, MO· 226 miles
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,098 Total Patients Enrolled
12 Trials studying Down Syndrome
18,341 Patients Enrolled for Down Syndrome
Children's Oncology GroupLead Sponsor
465 Previous Clinical Trials
240,330 Total Patients Enrolled
10 Trials studying Down Syndrome
11,321 Patients Enrolled for Down Syndrome
Maria M GramatgesPrincipal InvestigatorChildren's Oncology Group