Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT07159620
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D014751', 'term': 'Vindesine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Complete Remission Rate（CRc） after induction therapy', 'timeFrame': 'Time from the completion of induction and before consolidation therapy（up to 42 days）', 'description': 'Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)'}], 'secondaryOutcomes': [{'measure': 'Overall survival（OS）', 'timeFrame': '2 years', 'description': 'Time from the date of enrollment to death from any cause or the last follow-up'}, {'measure': 'Relapse-Free Survival(RFS)', 'timeFrame': '2 years', 'description': 'The duration from the date of the first complete remisson to the occurrence of relapse, death from any cause, or the last follow-up.'}, {'measure': 'duration of remission (DOR)', 'timeFrame': '2 years', 'description': 'Time between the first remission and relapse'}, {'measure': 'AE', 'timeFrame': 'Within 30 days after the last chemotherapy', 'description': 'Adverse events during the chemotherapy treatment.'}, {'measure': 'MRD', 'timeFrame': 'At the end of induction（up to 42 days）, 1 cycle of consolidation（up to 42 days）, 2 cycle of consolidation （up to 42 days）and the end of consolidation（up to 42 days）', 'description': 'Percentage of participants who converted to MRD \\< 10\\^-4 by flow cytometry'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult T-cell Leukemia/Lymphoma']}, 'descriptionModule': {'briefSummary': 'ETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: \\>14 to 65 years (inclusive).\n2. Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria:\n\n ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate ≤75%, and positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative.\n\n Near-ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate \\>75%, AND positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative.\n\n T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1.\n3. Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose \\<0.5g, and leukapheresis).\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n5. Expected survival \\>6 months.\n6. Demonstrated capacity to understand the study and willingness to provide informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential\n2. Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.\n3. Severe Organ Dysfunction:\n\n Cardiac Insufficiency: Left ventricular ejection fraction (LVEF) ≤40%, OR history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia.\n\n Respiratory Failure: Partial pressure of arterial oxygen (PaO₂) ≤60 mmHg. Hepatic Impairment: Total bilirubin ≥2 times the upper limit of normal (ULN), OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times ULN.\n\n Renal Impairment: Serum creatinine ≥2 mg/dL, OR creatinine clearance ≤30 mL/min/1.73m².\n\n Hypersensitivity: History of hypersensitivity to any of the study drugs or compounds of similar chemical structure.\n4. Presence of central nervous system (CNS) leukemia.\n5. Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.'}, 'identificationModule': {'nctId': 'NCT07159620', 'briefTitle': 'Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'A Prospective Single-Arm Clinical Study of Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients', 'orgStudyIdInfo': {'id': '2025662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone', 'description': 'Induction Therapy Phase:\n\nVACVP induction:Venetoclax: 100mg, d1, 200mg, d2, 400mg, d3-d21, orally. Azacitidine,75mg/m²/day, d1-d7, subcutaneously. Chidamide,10mg, d1-d7, orally. Vindesine, 4mg, d1, intravenous infusion. Dexamethasone,9mg/m²/day, d1-d14; reduced by half on d15-d17; further reduced by half on d18-d21, intravenous infusion or orally.\n\nConsolidation therapy:\n\n1. alternate use of HD-MTX-Ara C and VACVP\n2. allogeneic hematopoietic stem cell transplantation (HSCT)', 'interventionNames': ['Drug: VEN (Venetoclax)', 'Drug: Azacitidine (AZA)', 'Drug: Chidamide', 'Drug: vindesine', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'VEN (Venetoclax)', 'type': 'DRUG', 'description': 'Orally', 'armGroupLabels': ['Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone']}, {'name': 'Azacitidine (AZA)', 'type': 'DRUG', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone']}, {'name': 'Chidamide', 'type': 'DRUG', 'description': 'Orally', 'armGroupLabels': ['Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone']}, {'name': 'vindesine', 'type': 'DRUG', 'description': 'intravenous infusion', 'armGroupLabels': ['Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'intravenous infusion or orally', 'armGroupLabels': ['Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Xu', 'role': 'CONTACT', 'email': 'xuyang1020@126.com', 'phone': '86+051267972685'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Yang Xu', 'role': 'CONTACT', 'email': 'xuyang1020@126.com', 'phone': '86+051267781850'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}