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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 39 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at long-term health after treatment for acute leukemia, a fast-growing blood cancer. It is for people ages 6 to 39 with Down syndrome who finished cancer treatment at least 3 years ago. The goal is to help improve care after cancer treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 6 to 39 when joining the study.
  • Have Down syndrome. Any of the three types is allowed.
  • Have been treated for acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). This includes myeloid leukemia of Down syndrome, including myelodysplastic syndrome, a bone marrow disorder.
  • Have finished all cancer treatment at least 36 months ago. People whose leukemia came back may join if they meet all study rules.
  • Be expected to live more than 1 year.
  • The patient and parent must speak English or Spanish. At least one parent or guardian must read and write in English or Spanish and complete all surveys, even for adult patients.
  • The patient and/or parent or legal guardian must sign a form agreeing to join.
  • All required rules for research with people must be met.

Who can't join

  • Have had a blood-forming stem cell transplant. Past CAR T-cell therapy or other cancer treatments using cells are allowed if all other study rules are met.
  • Have had another cancer before or after the ALL or AML diagnosis.
  • Have a parent or guardian who cannot complete the required forms.
  • Have only had transient abnormal myelopoiesis (TAM), a temporary blood cell disorder, without qualifying leukemia. Past TAM is allowed but does not qualify someone on its own.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (72)

AL

AZ

CA

CT

DE

FL

GA

HI

  • Kapiolani Medical Center for Women and Children · Honolulu, HI 96826Site Public Contact · Study contact · 808-983-6090Wade T. Kyono · Principal investigatorMore trials in Honolulu

IL

MD

MI

MN

MO

MS

  • University of Mississippi Medical Center · Jackson, MS 39216Site Public Contact · Study contact · 601-815-6700Amanda Strobel · Principal investigatorMore trials in Jackson

NC

ND

NE

NJ

NV

NY

OH

OK

OR

PA

RI

SC

SD

TN

TX

WA

WI