Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT06297551
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2024-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, '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.\n\nBiomarkers 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.\n\nIn this study investigators will study 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. A retrospective study 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.\n\nThis pilot study will allow the investigators 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults diagnosed with acute myeloid leukemia, undergoing systemic chemotherapy (high or low intensity)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of acute myeloid leukemia\n* ability to receive treatment for acute myeloid leukemia at the research center\n* elevated values of CLL1A and CD45RA positive cells at the time of diagnosis'}, 'identificationModule': {'nctId': 'NCT06297551', 'briefTitle': 'Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Prospective Study of Leukemia Stem Cells Fractional Change in Peripheral Blood and Its Correlation With Therapeutic Outcome in Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'SBU-AML-LSC'}, 'secondaryIdInfos': [{'id': 'IRB2023-00528', 'type': 'OTHER', 'domain': 'Stony Brook University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'During induction therapy for AML, researchers will measure the relative percentage of hematopoietic stem cells (defined by markers CD34+/CD38-) that test positive for CLL1 and CD45RA surface markers in the blood of participants on day 3, 5 and 7 days of systemic therapy. The variation of blood cells positivity for these markers, will be correlated with treatment outcome (complete response, partial response, no response), as determined by a bone marrow biopsy done approximately 4 weeks after induction chemotherapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caterina Vacchi-Suzzi, PhD', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@stonybrookmedicine.edu', 'phone': '631-728-7425'}, {'name': 'Suhu Liu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'centralContacts': [{'name': 'Caterina Vacchi-Suzzi, PhD', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@stonybrookmedicine.edu', 'phone': '631-728-7425'}], 'overallOfficials': [{'name': 'Suhu Liu, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suhu Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Suhu Liu', 'investigatorAffiliation': 'Stony Brook University'}}}}