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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
B Acute Lymphoblastic Leukemia Associated With Down Syndrome
Intervention / Treatment

-

Contacts and Locations

Madera

Valley Children's Hospital, Madera, California, United States, 93636

Oakland

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States, 94609

San Francisco

UCSF Medical Center-Mission Bay, San Francisco, California, United States, 94158

Wilmington

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States, 19803

Fort Myers

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States, 33908

Hollywood

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States, 33021

Jacksonville

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States, 32207

Orlando

Nemours Children's Hospital, Orlando, Florida, United States, 32827

Tampa

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States, 33607

Atlanta

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States, 30329

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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: 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
  • * 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 forms, 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
  • * 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

Ages Eligible for Study

6 Years to 39 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Oncology Group,

Maria M Gramatges, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

2028-12-16