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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients age \>= 6 and \< 40 years at the time of enrollment
* A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells)
* All patients must be DS-AL survivors (acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\])
* Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant
* Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study
* 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
* All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment
* Patients must have a life expectancy of \> 1 year
* Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish
* Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are \>= 18 years old
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with history of hematopoietic stem cell transplant (HSCT) are excluded
* Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied
* Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded
* Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility
* Patients whose parents or guardians are unable to complete the required forms are excluded
Primary outcome measure(s)
Prevalence, type, and severity of chronic health conditions (CHC) — Up to study completion Summary statistics will be used to characterize the study populations on CHC outcomes. Quantitative data (number of comorbidities) will be summarized using descriptive statistics and correlational techniques. Will use pooled logistic regression to estimate overall response, 95% confidence interval (CI), and p-values for association of acute leukemia (AL) diagnosis with medical record-verified CHC, agnostic of time to CHC. Will use stratified Cox models to refine associations of AL diagnosis with CHC based on time to CHC incidence. Within each age interval, will estimate the hazard ratio, 95% CI, and p-values to report time-dependent effects of AL diagnosis on CHC.
Trial sites (73)
Facility
City
Region
Status
Children's Hospital of Alabama
Birmingham
Alabama
Recruiting
Phoenix Childrens Hospital
Phoenix
Arizona
Recruiting
Valley Children's Hospital
Madera
California
Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland
California
Recruiting
Kaiser Permanente-Oakland
Oakland
California
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento
California
Recruiting
Rady Children's Hospital - San Diego
San Diego
California
Recruiting
UCSF Medical Center-Mission Bay
San Francisco
California
Recruiting
Yale University
New Haven
Connecticut
Recruiting
Alfred I duPont Hospital for Children
Wilmington
Delaware
Recruiting
Golisano Children's Hospital of Southwest Florida
Fort Myers
Florida
Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Florida
Recruiting
Nemours Children's Clinic-Jacksonville
Jacksonville
Florida
Recruiting
Nemours Children's Hospital
Orlando
Florida
Recruiting
Nemours Children's Clinic - Pensacola
Pensacola
Florida
Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Florida
Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta
Georgia
Recruiting
Augusta University Medical Center
Augusta
Georgia
Recruiting
Kapiolani Medical Center for Women and Children
Honolulu
Hawaii
Recruiting
Lurie Children's Hospital-Chicago
Chicago
Illinois
Recruiting
University of Chicago Comprehensive Cancer Center
Chicago
Illinois
Recruiting
Sinai Hospital of Baltimore
Baltimore
Maryland
Recruiting
C S Mott Children's Hospital
Ann Arbor
Michigan
Recruiting
Children's Hospital of Michigan
Detroit
Michigan
Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids
Michigan
Recruiting
Bronson Methodist Hospital
Kalamazoo
Michigan
Recruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis
Minnesota
Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis
Minnesota
Recruiting
University of Mississippi Medical Center
Jackson
Mississippi
Recruiting
Children's Mercy Hospitals and Clinics
Kansas City
Missouri
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Children's Hospital and Medical Center of Omaha
Omaha
Nebraska
Recruiting
University of Nebraska Medical Center
Omaha
Nebraska
Recruiting
University Medical Center of Southern Nevada
Las Vegas
Nevada
Recruiting
Sunrise Hospital and Medical Center
Las Vegas
Nevada
Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Nevada
Recruiting
Summerlin Hospital Medical Center
Las Vegas
Nevada
Recruiting
Renown Regional Medical Center
Reno
Nevada
Recruiting
Hackensack University Medical Center
Hackensack
New Jersey
Recruiting
Albany Medical Center
Albany
New York
Recruiting
+ 33 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.