Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT06066905
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Chidamide With AZA in MRD Positive AML After Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D018365', 'term': 'Neoplasm, Residual'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'T cell receptor excision circles (TRECs) level before and after treatment', 'timeFrame': '24 months', 'description': 'T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor.'}, {'measure': 'the rate of MRD turn negative in molecular genetic abnormality subtype', 'timeFrame': '24 months', 'description': 'minimal residual disease'}], 'primaryOutcomes': [{'measure': 'the rate of RFS in 6 months', 'timeFrame': '6 months', 'description': 'relapse-free survival'}], 'secondaryOutcomes': [{'measure': 'the rate of MRD turn negative in 6 months', 'timeFrame': '6 months', 'description': 'minimal residual disease turn negative'}, {'measure': 'the time length of MRD negative', 'timeFrame': '24 months', 'description': 'minimal residual disease negative'}, {'measure': 'the 1 year/2 year RFS', 'timeFrame': '24 months', 'description': 'relapse-free survival'}, {'measure': 'the 1 year/2 year OS', 'timeFrame': '24 months', 'description': 'overall survival'}, {'measure': 'the rate of GVHD', 'timeFrame': '24 months', 'description': 'graft-versus-host disease'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '24 months', 'description': 'Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AML, Adult', 'Minimal Residual Disease']}, 'descriptionModule': {'briefSummary': 'acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.', 'detailedDescription': 'Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n2. ≥18 years old;\n3. ECOG≤3;\n4. lifespan≥3 months;\n5. Take contraceptive measures;\n6. Sign informed consent.\n\nExclusion Criteria:\n\n1. Allergic to the study drug;\n2. A gastrointestinal condition that prevents oral medication;\n3. active infection;\n4. Dysfunction of vital organs;\n5. other malignancies;\n6. HIV infection;\n7. HBV or HCV;\n8. The QT interval is prolonged;\n9. Pregnant or lactating women;\n10. Is participating in other clinical studies;\n11. The researchers did not consider it appropriate to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06066905', 'briefTitle': 'A Study of Chidamide With AZA in MRD Positive AML After Transplant', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Study of Chidamide With AZA in MRD Positive AML After Transplant', 'orgStudyIdInfo': {'id': 'Chidaza101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chidamide and azacitidine', 'interventionNames': ['Drug: chidamide and azacitidine']}], 'interventions': [{'name': 'chidamide and azacitidine', 'type': 'DRUG', 'description': 'chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally.\n\nazacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.', 'armGroupLabels': ['chidamide and azacitidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'WENG jian yu, M.D.', 'role': 'CONTACT', 'email': 'wsswjy@sina.com', 'phone': '（020）83827812'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'WENG jian yu, M.D.', 'role': 'CONTACT', 'email': 'wengjianyu1969@163.com', 'phone': '020-83827812'}, {'name': 'Ling Wei, M.D.', 'role': 'CONTACT', 'email': 'nick97@163.com', 'phone': '020-83827812'}], 'overallOfficials': [{'name': 'WENG jian yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Hematology, Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen Chipscreen Biosciences Co.Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'WENG Jian yu', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}