IRB Study Number 25-079
Status Recruiting
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.
1.2 Secondary Objectives
1.2.1 To characterize post-treatment clinical outcomes of DS-AL by prospective, in-person assessment.
1.2.2 To determine the prevalence and severity of parent-reported neuropsychological (NP) in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history.
1.2.3 To determine health-related quality of life (HRQOL) in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history.
1.2.4 To identify clinical risk determinants of CHC, NP, and clinical outcomes in survivors of DS-AL.
1.2.5 To establish a well-annotated cohort of survivors of DS-AL and associated biobank as a resource for future investigations.
Inclusion Criteria
3.2.1 Age
Patients age ≥ 6 and < 40 years at the time of enrollment.
3.2.2 Diagnosis
3.2.2.1 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).
3.2.2.2 All patients must be DS-AL survivors (ALL or 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 (see 3.2.4) and did not include stem cell transplant (see 3.2.7).
3.2.3 Prior Therapy
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.
3.2.4 Timing
All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment.
3.2.5 Life Expectancy
Patients must have a life expectancy of > 1 year.
3.2.6 Language
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.
Exclusion Criteria
3.2.7.1 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.
3.2.7.2 Patients with a history of cancer 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.
3.2.7.3 Patients whose parents or guardians are unable to complete the required forms are excluded.
