protocolSection identificationModule nctId: NCT06297551, orgStudyIdInfo id: SBU-AML-LSC, secondaryIdInfos id: IRB2023-00528, type: OTHER, domain: Stony Brook University, briefTitle: Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Suhu Liu, class: OTHER, descriptionModule briefSummary: Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry, outcomesModule primaryOutcomes measure: Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stony Brook Cancer Center, status: RECRUITING, city: Stony Brook, state: New York, zip: 11794, country: United States, contacts name: Caterina Vacchi-Suzzi, PhD, role: CONTACT, phone: 631-728-7425, email: cancerclinicaltrials@stonybrookmedicine.edu, contacts name: Suhu Liu, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False