RECRUITING

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

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Conditions

B Acute Lymphoblastic Leukemia Associated With Down SyndromeDown SyndromeMyeloid Leukemia Associated With Down Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

Quick Facts

Study Start:2023-06-12
Study Completion:2028-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05702645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients age \>= 6 and \< 40 years at the time of enrollment
  2. * 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)
  3. * All patients must be DS-AL survivors (acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\])
  4. * Note: Myeloid leukemia of Down syndrome (ML-DS) would be included under AML category above. 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
  5. * Patients must have been treated for ALL or AML
  6. * Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above
  7. * All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment
  8. * Patients must have a life expectancy of \> 1 year
  9. * 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
  10. * Note: Parents or guardians are responsible for completing all forms, even in the case of subjects that are \>= 18 years old
  11. * All patients and/or their parents or legal guardians must sign a written informed consent
  12. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  1. * Patients with history of hematopoietic stem cell transplant (HSCT) are excluded
  2. * 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
  3. * 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
  4. * Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility
  5. * Patients whose parents or guardians are unable to complete the required forms are excluded

Contacts and Locations

Principal Investigator

Maria M Gramatges
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Valley Children's Hospital
Madera, California, 93636
United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
United States
Nemours Children's Hospital
Orlando, Florida, 32827
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Maria M Gramatges, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2028-12-16

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2028-12-16

Terms related to this study

Additional Relevant MeSH Terms

  • B Acute Lymphoblastic Leukemia Associated With Down Syndrome
  • Down Syndrome
  • Myeloid Leukemia Associated With Down Syndrome