Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT06486350
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IL-6: A Marker for AML Chemo Sensitivity
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bone marrow supernatant'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-30', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-30', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '1 year', 'description': 'The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy'}], 'secondaryOutcomes': [{'measure': 'CR', 'timeFrame': '1 year', 'description': 'The secondary endpoints is the complete remission (CR) rate after Chemotherapy'}, {'measure': 'CRi', 'timeFrame': '1 year', 'description': 'The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy'}, {'measure': 'PR', 'timeFrame': '1 year', 'description': 'The secondary endpoints is the partial remission (PR) rate after Chemotherapy'}, {'measure': 'OS', 'timeFrame': '2 year', 'description': 'The secondary endpoints is the overall survival (OS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'IL-6', 'Chemotherapy sensitivity'], 'conditions': ['AML, Adult']}, 'referencesModule': {'references': [{'pmid': '40668612', 'type': 'DERIVED', 'citation': 'Hou D, Cai D, Dai W, Liao X, Tan M, Zheng X, Wang L, Liu J, Wang J, Wang X, Fu Q, Huang H. Targeting bone marrow mesenchymal stromal cell-derived IL-6 to overcome acute myeloid leukemia chemoresistance. Blood Adv. 2025 Oct 14;9(19):4810-4824. doi: 10.1182/bloodadvances.2024015496.'}]}, 'descriptionModule': {'briefSummary': 'Acute myeloid leukemia (AML) is a clonal malignancy that arises from the primitive hematopoietic cells within the hematopoietic system. According to SEER cancer statistics, the 5-year survival rate for AML patients stands at a concerning 30%. Despite therapeutic advancements, the development of chemotherapy resistance and the risk of disease relapse pose significant barriers to curative outcomes. Evidence has linked elevated interleukin-6 (IL-6) levels in plasma and bone marrow to a poorer prognosis in AML, with IL-6 potentially fostering chemotherapy resistance through the enhancement of fatty acid uptake and the induction of stromal-like morphological changes in AML cells. However, the role of IL-6 as a potential biomarker for monitoring chemotherapy sensitivity in AML has not been fully elucidated. This study seeks to investigate the correlation between IL-6 levels in bone marrow supernatant and the sensitivity to chemotherapy, offering a clinical perspective that could pave the way for improved prognostic markers and personalized treatment strategies.', 'detailedDescription': 'In this prospective study, we will collect bone marrow supernatant samples from patients diagnosed with Acute Myeloid Leukemia (AML) to evaluate the levels of Interleukin-6 (IL-6). Our aim is to explore whether elevated IL-6 levels can serve as a predictive biomarker for poor treatment outcomes following standard chemotherapy regimens. The findings may help in stratifying patient risk and personalizing therapeutic approaches in AML treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study enrolls patients who fulfill the diagnostic criteria for AML (excluding APL), with an age requirement of over 18 years and no restrictions on gender. Participation is entirely voluntary, with each participant or their legal guardian being thoroughly informed about the study details and signing an informed consent form. Participants are willing to adhere to and capable of completing all required study procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis aligns with the "Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)";\n2. All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;\n3. Patients participate in the study accompanied by family members and sign informed consent documents.\n\nExclusion Criteria:\n\n1. Patients with concurrent malignancies requiring treatment;\n2. Presence of infectious diseases, including SARS, viral hepatitis, or HIV/AIDS;\n3. Major surgery performed within the last 21 days;\n4. Performance Status (PS) score \\>3;\n5. Severe liver or kidney dysfunction or serious infection;\n6. Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.'}, 'identificationModule': {'nctId': 'NCT06486350', 'briefTitle': 'IL-6: A Marker for AML Chemo Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'Bone Marrow Supernatant IL-6 as a Predictor of Chemotherapy Sensitivity in AML Patients', 'orgStudyIdInfo': {'id': 'AML-IL6'}}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'huifang huang', 'role': 'CONTACT', 'email': 'huanghuif@fjmu.edu.cn', 'phone': '13365910318', 'phoneExt': '0591-86218641'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Huifang Huang', 'role': 'CONTACT', 'email': 'huanghuif@fjmu.edu.cn', 'phone': '13365910318', 'phoneExt': '0591-86218641'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Huifang Huang, MD', 'investigatorAffiliation': 'Fujian Medical University Union Hospital'}}}}