Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-28 @ 7:59 AM
Study NCT ID:
NCT07131059
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRD-positive AML Clinical Study
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': 'C000627630', 'term': 'ivosidenib'}, {'id': 'C000609080', 'term': 'gilteritinib'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'C000707147', 'term': 'avapritinib'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relapse-free survival rate', 'timeFrame': 'up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Measurable Residual Disease', 'timeFrame': 'up to 6 months'}, {'measure': 'Proportion of MRD turning negative', 'timeFrame': 'up to 6 months'}, {'measure': 'Overall survival(OS ) rate', 'timeFrame': 'From the time the patients participated in the clinical trial until the patient died'}, {'measure': 'Cumulative relapse rate', 'timeFrame': 'From the time the patients participated in the clinical trial until the patient relapsed'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'up to 2 years'}, {'measure': 'The incidence of adverse events such as serious infections during treatment', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Measurable Residual Disease'], 'conditions': ['AML, Adult']}, 'descriptionModule': {'briefSummary': 'This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.', 'detailedDescription': 'Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11\\[4\\]. NGS can detect mutations such as FLT3.\n\nFor eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time.\n\nThis study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* AML (non-M3) compliant with WHO (2016) standards;\n* In morphological complete remission.\n* Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.\n* Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n* Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks\n* The diagnosis is APL\n* Those who were not considered suitable for inclusion by the researchers."}, 'identificationModule': {'nctId': 'NCT07131059', 'briefTitle': 'MRD-positive AML Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study', 'orgStudyIdInfo': {'id': 'IIT2024032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With lDH1 gene mutation', 'description': 'Ivosidenib 500mg/d d1-28 ；Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d:d1-28', 'interventionNames': ['Drug: Ivosidenib', 'Drug: Venetoclax']}, {'type': 'EXPERIMENTAL', 'label': 'FLT3 gene mutation', 'description': 'Gilteritinilb 120mg/d, d1 -28； Venetocax 400mg/d d1-28 400mg', 'interventionNames': ['Drug: Gilteritinib', 'Drug: Venetoclax']}, {'type': 'EXPERIMENTAL', 'label': 'NPM1 mutation or IDH2 mutation', 'description': 'Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d d1-21 or Cytarabine 20mg/m2/d d1-10；Venetoclax 600mg/d d1-21', 'interventionNames': ['Drug: Venetoclax']}, {'type': 'EXPERIMENTAL', 'label': 'c-kit mutation', 'description': 'Avapritinib 200mg/ day, 28 days a course', 'interventionNames': ['Drug: Avapritinib']}, {'type': 'EXPERIMENTAL', 'label': 'Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax', 'description': 'Cytarabine 100mg/m2/d, d1-5； Daunorubicin 45mg/m2/d，d1-2；or Idarubicin 10mg/ m2/d，d1-2；or MTZ 8mg/ m2/d d1-2; Venetoclax 400mg d1-7', 'interventionNames': ['Drug: Venetoclax', 'Drug: Daunorubicin', 'Drug: Cytarabine', 'Drug: Idarubicin', 'Drug: MTZ']}, {'type': 'EXPERIMENTAL', 'label': 'Cytarabine+HHT+Venetoclax', 'description': 'Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7', 'interventionNames': ['Drug: Venetoclax', 'Drug: Cytarabine', 'Drug: HHT']}, {'type': 'EXPERIMENTAL', 'label': 'Venetoclax+Azacitidine/Venetoclax+Cytarabine', 'description': 'Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21', 'interventionNames': ['Drug: Venetoclax', 'Drug: Cytarabine', 'Drug: Azacitidine']}], 'interventions': [{'name': 'Ivosidenib', 'type': 'DRUG', 'description': '500mg d1-28', 'armGroupLabels': ['With lDH1 gene mutation']}, {'name': 'Gilteritinib', 'type': 'DRUG', 'description': '120mg d1-28', 'armGroupLabels': ['FLT3 gene mutation']}, {'name': 'Venetoclax', 'type': 'DRUG', 'description': '400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21', 'armGroupLabels': ['Cytarabine+HHT+Venetoclax', 'Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax', 'FLT3 gene mutation', 'NPM1 mutation or IDH2 mutation', 'Venetoclax+Azacitidine/Venetoclax+Cytarabine', 'With lDH1 gene mutation']}, {'name': 'Avapritinib', 'type': 'DRUG', 'description': '200mg d1-28.', 'armGroupLabels': ['c-kit mutation']}, {'name': 'Daunorubicin', 'type': 'DRUG', 'description': '45mg/m2/d d1-2;', 'armGroupLabels': ['Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax']}, {'name': 'Cytarabine', 'type': 'DRUG', 'description': '100mg/m2/d d1-5', 'armGroupLabels': ['Cytarabine+HHT+Venetoclax', 'Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax', 'Venetoclax+Azacitidine/Venetoclax+Cytarabine']}, {'name': 'Idarubicin', 'type': 'DRUG', 'description': '10mg/m2/d d1-2', 'armGroupLabels': ['Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax']}, {'name': 'MTZ', 'type': 'DRUG', 'description': '8mg/m2/d d1-2', 'armGroupLabels': ['Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax']}, {'name': 'HHT', 'type': 'DRUG', 'description': '2mg/m2/d d1-5', 'armGroupLabels': ['Cytarabine+HHT+Venetoclax']}, {'name': 'Azacitidine', 'type': 'DRUG', 'description': '75mgd/m2 d1-7.', 'armGroupLabels': ['Venetoclax+Azacitidine/Venetoclax+Cytarabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Wei, MD', 'role': 'CONTACT', 'email': 'weihui@ihcams.ac.cn', 'phone': '86-13132507161'}], 'facility': 'Blood Diseases Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Hui Wei, Doctor', 'role': 'CONTACT', 'email': 'weihui@ihcams.ac.cn', 'phone': '13132507161'}], 'overallOfficials': [{'name': 'Huui Wei, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}