Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT06763666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Complete remission (cCR, CR+CRi)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Will compare composite complete remission(CR+CRi: complete response \\[CR\\] and complete response with incomplete blood count recovery \\[CRi\\]) between CLAGV regimen and CLAG regimen'}], 'secondaryOutcomes': [{'measure': 'Overall Response rate (ORR)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Will compare ORR(completed remission\\[CR\\], completed remission with incomplete blood count recovery\\[CRi\\], and partial remission\\[PR\\]) rates between the study arms'}, {'measure': 'MRDneg CR rate', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Will compare MRD-negative cCR rates between the study arms'}, {'measure': 'Overall Survival(OS)', 'timeFrame': '1 year post treatment', 'description': 'Will compare OS between the study arms'}, {'measure': 'Relapse free survival(RFS)', 'timeFrame': '1 year post treatment', 'description': 'Will compare RFS between the study arms'}, {'measure': 'Duration of completed response(DoR)', 'timeFrame': '1 year post treatment', 'description': 'Will compare DoR between the study arms'}, {'measure': 'Relapse rate', 'timeFrame': '1 year post treatment', 'description': 'Will compare relapse rate between the study arms'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Duration of treatment, up to 1 year', 'description': 'Will use the CTCAE (National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events) version 5.0 for toxicity and adverse event reporting. Will describe the incidence of infection and treatment-related adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory AML']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.', 'detailedDescription': 'The efficacy and prognosis of relapsed/refractory(r/r) AML are very poor, and there is no standard chemotherapy regimen were defined for r/r AML. Cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on AML cells. Previous studies have confirmed the efficacy of cladribine in the treatment of r/r AML, with a response rate of 30-45%.Our previous experience has shown that CLAG in combination of venetoclax are effective with tolerable toxicity profiling. However, there is a lack of multicenter, prospective, randomized controlled trials to further confirm the results. Therefore, a clinical study is planned to evaluate the efficacy and safety of CLAG+VEN compared to CLAG in r/r AML who were eligible for intensive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed of AML according to the World Health Organization (WHO) classification.\n2. All patients should aged 18 to 65 years.\n3. Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）\n4. Diagnostic criteria for relapsed AML: Leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) after CR, or leukemia cell infiltration appears outside the marrow.\n5. Diagnostic criteria for refractory AML: The newly diagnosed patients who failed to respond to two courses of standard treatment; Patients who relapsed within 12 months after consolidation intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.\n6. The score of Eastern Cooperative Oncology Group (ECOG) is 0-2.\n7. Renal function: creatinine clearance rate ≥ 30ml/min.\n8. Liver function: ALT\\<5 times normal value, bilirubin\\<3 times normal value.\n9. Predicted survival ≥ 3 months.\n10. Able to accept oral Venetoclax.\n11. Sign an informed consent form and be able to understand and follow the procedures required by this protocol.\n\nExclusion Criteria:\n\n1. Diagnosed of acute promyelocytic leukemia (AML-M3)\n2. Patients with central nervous system (CNS) invasion.\n3. Cardiac function \\< grade 2.\n4. Known human immunodeficiency virus (HIV) infection.\n5. Other clinically significant uncontrolled conditions, including but not limited to: a. uncontrolled or active systemic infections (viruses, bacteria, or fungi); b. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; c. Secondary tumors requiring active treatment.\n6. Allergy to experimental drugs.\n7. Pregnant and lactating women.\n8. Patients who ineligible for the study according to the investigator's assessment."}, 'identificationModule': {'nctId': 'NCT06763666', 'briefTitle': 'CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Multicenter, Prospective, Randomized Controlled Study Comparing the Efficacy and Safety of CLAG(Cladribine, Cytarabine and G-CSF) Combined With Venetoclax and CLAG in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'NFEC-2024-639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLAGV regimen', 'description': 'CLAG combined with venetoclax for relapsed/refractory AML. Patients were randomized and those entering the experimental group received cladribine, cytarabine, G-CSF and venetoclax.\n\nVenetoclax is administered orally at 400mg/d on days 2-8. When combination with P450 3A4 inhibitor, VEN should be reduced to 100-200mg/d and monitoring of VEN blood concentrations is recommended at qualified centers. Cladribine is administered intravenously at a dose of 5 mg/m2/d on days 1-5. Cytarabine is administered intravenously at a dose of 1g/m2/d on days 1-5, starting 2h after cladribine and maintained for more than 3h. The dose of G-CSF was 5ug/kg/d subcutaneously injected on days 0-5. Generally, starting 12 hours before the start of chemotherapy, if the absolute value of white blood cell count is ≥ 20×10\\^9/L, the use is suspended.For patients with FLT3 mutations, corresponding inhibitors such as sorafenib and gilteritinib can be combined.', 'interventionNames': ['Drug: Cladribine', 'Drug: Cytarabine', 'Drug: G-CSF', 'Drug: Venetoclax']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CLAG regimen', 'description': 'CLAG regimen for relapsed/refractory AML. Patients were randomized and those entering the experimental group received cladribine, cytarabine, G-CSF.\n\nCladribine is administered intravenously at a dose of 5 mg/m2/d on days 1-5. Cytarabine is administered intravenously at a dose of 1g/m2/d on days 1-5, starting 2h after cladribine and maintained for more than 3h. The dose of G-CSF was 5ug/kg/d subcutaneously injected on days 0-5. Generally, starting 12 hours before the start of chemotherapy, if the absolute value of white blood cell count is ≥ 20×10\\^9/L, the use is suspended.For patients with FLT3 mutations, corresponding inhibitors such as sorafenib and gilteritinib can be combined.', 'interventionNames': ['Drug: Cladribine', 'Drug: Cytarabine', 'Drug: G-CSF']}], 'interventions': [{'name': 'Cladribine', 'type': 'DRUG', 'otherNames': ['2-CdA', 'CdA'], 'description': 'Given IV', 'armGroupLabels': ['CLAG regimen', 'CLAGV regimen']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['Ara-C'], 'description': 'Given IV', 'armGroupLabels': ['CLAG regimen', 'CLAGV regimen']}, {'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['Filgrastim', 'Granulocyte Colony-stimulating Factor'], 'description': 'Given SC', 'armGroupLabels': ['CLAG regimen', 'CLAGV regimen']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['Venclexta'], 'description': 'Given PO', 'armGroupLabels': ['CLAGV regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Guopan Yu', 'role': 'CONTACT', 'email': 'yugpp@163.com', 'phone': '+8615876559968'}], 'facility': 'Department of Hematology,Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Guopan Yu', 'role': 'CONTACT', 'email': 'yugpp@163.com', 'phone': '+8615876559968'}, {'name': 'Guopan Yu', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Guopan Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': "Guangzhou No.12 People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Guangzhou Panyu Central Hospital', 'class': 'OTHER'}, {'name': 'Guangzhou General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Foresea Life Insurance Guangzhou General Hospital', 'class': 'UNKNOWN'}, {'name': 'Guangdong Second Provincial General Hospital', 'class': 'OTHER'}, {'name': 'Jiangmen Central Hospital', 'class': 'OTHER'}, {'name': 'Shantou Central Hospital', 'class': 'OTHER'}, {'name': "Maoming People's Hospital", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Hainan General Hospital', 'class': 'OTHER'}, {'name': "Dongguan People's Hospital", 'class': 'OTHER_GOV'}, {'name': 'Tungwah Hospital of Sun Yat-Sen University', 'class': 'UNKNOWN'}, {'name': 'Shenzhen Hospital of Southern Medical University', 'class': 'OTHER'}, {'name': "Central People's Hospital of Zhanjiang", 'class': 'OTHER'}, {'name': 'ZhuHai Hospital', 'class': 'OTHER'}, {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': "LiuZhou People's Hospital", 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Guangdong Medical University', 'class': 'OTHER'}, {'name': 'Guilin Medical University, China', 'class': 'OTHER'}, {'name': "Yuebei People's Hospital", 'class': 'OTHER'}, {'name': 'Huizhou Municipal Central Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}