[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597489":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":50,"locations":56,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":9,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":90,"conditions":91,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Shanxi Bethune Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL","EXPERIMENTAL",null,[13,14,15,16,17,18,19],"Drug: Induction Therapy Regimen","Drug: Pre-Treatment Regimen","Other: Post-CR Treatment","Drug: Post-CR Consolidation Regimens","Other: Transplant-Eligible Subsequent Therapy","Other: Allo-HSCT Protocol","Other: Non-Transplant Maintenance Therapy Options",[21,26,30,34,38,42,46],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Induction Therapy Regimen","VICP+VEN regimen:\n\n* Vindesine: 3 mg\u002Fm²\u002Fday (max 4 mg), administered on days 1, 8, 15, 22.\n* Idarubicin (IDA): 8 mg\u002Fm², days 1, 8, 15, 22.\n* Cyclophosphamide (CTX): 500 mg\u002Fm², days 7, 21.\n* Prednisone: 1 mg\u002Fkg\u002Fday, days 1-14; 0.5 mg\u002Fkg\u002Fday, days 15-28\n* Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg\u002Fday",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Pre-Treatment Regimen","Indications for pre-treatment:\n\n* WBC ≥30×10⁹\u002FL, or significant hepatosplenomegaly\u002Flymphadenopathy.\n* Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities).\n\nPre-treatment protocol:\n\n* Glucocorticoids (e.g., prednisone or dexamethasone): Prednisone 1 mg\u002Fkg\u002Fday (PO\u002FIV) for 3-5 days.\n* Optional addition of CTX: 200 mg\u002Fm²\u002Fday IV for 3-5 days.",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Post-CR Treatment","Principles:\n\n1. MRD-positive or rising: Administer blinatumomab (CD19\u002FCD3 bispecific antibody) for residual disease clearance, followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. MRD-negative\u002Funknown: Continue multi-agent chemotherapy ± blinatumomab consolidation. Allo-HSCT for patients with high-risk clinical\u002Fgenetic features.",[9],{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"Post-CR Consolidation Regimens","① Hyper-CVAD-B (Methotrexate\u002FCytarabine-based):\n\n* Methotrexate (MTX): 1 g\u002Fm² IV over 24h (Day 1) with urine alkalinization (pH \\>7.0) and leucovorin rescue.\n* Cytarabine (Ara-C): 1 g\u002Fm² IV q12h (Days 2-3; total 4 doses).\n* Dexamethasone: 40 mg\u002Fday (PO\u002FIV, Days 1-4).\n* Cycle interval: 21-28 days (alternating with other regimens).\n\n  ② CAM Regimen:\n* CTX: 750 mg\u002Fm² IV (split over 2 days).\n* Ara-C: 75 mg\u002Fm²\u002Fdose (8 days; 1-2 doses\u002Fday IV; if once daily, administer 5 days\u002Fweek × 2 weeks).\n* 6-MP: 50-75 mg\u002Fm²\u002Fday fasting (7-14 days PO).",[9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"Transplant-Eligible Subsequent Therapy","* Allo-HSCT for eligible patients after induction.\n* Conditioning regimen: TBI-VP16-CY.\n* Donor priority: HLA-matched sibling donor (MSD), Matched unrelated donor (MUD), Haploidentical donor (Haplo).(Consider age\u002Fdonor health status).",[9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"Allo-HSCT Protocol","1.6.1 Conditioning Regimen (TBI-VP16-Cy\u002FATG):\n\n* TBI: 5 Gy (Days -7 to -6).\n* VP16: 10 mg\u002Fkg\u002Fday (Days -5 to -4).\n* CTX: 30 mg\u002Fkg\u002Fday (Days -3 to -2).\n* ATG: 7.5 mg\u002Fkg\u002Fday (Days -5 to -2). 1.6.2 GVHD Prophylaxis:\n* Basiliximab (anti-CD25 mAb): 50 mg (Days +1, +4).\n* Standard regimen: Cyclosporine (CsA): IV: 2 mg\u002Fkg\u002Fday (start Day -9; target level 150-250 μg\u002FL). PO: 3-5 mg\u002Fkg\u002Fday BID (switch delayed until Day +10 if no aGVHD); Mycophenolate mofetil (MMF) + short-course methotrexate.",[9],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"Non-Transplant Maintenance Therapy Options","① Hyper-CVAD-B (Methotrexate\u002FCytarabine-based):\n\n* Methotrexate (MTX): 1 g\u002Fm² IV over 24h (Day 1) with urine alkalinization (pH \\>7.0) and leucovorin rescue.\n* Cytarabine (Ara-C): 1 g\u002Fm² IV q12h (Days 2-3; total 4 doses).\n* Dexamethasone: 40 mg\u002Fday (PO\u002FIV, Days 1-4).\n* Cycle interval: 21-28 days (alternating with other regimens).\n\n  ② CAM Regimen:\n* CTX: 750 mg\u002Fm² IV (split over 2 days).\n* Ara-C: 75 mg\u002Fm²\u002Fdose (8 days; 1-2 doses\u002Fday IV; if once daily, administer 5 days\u002Fweek × 2 weeks).\n* 6-MP: 50-75 mg\u002Fm²\u002Fday fasting (7-14 days PO).\n\n  * Maintenance (6-MP\u002FMTX alternating with V-Dex): 6-MP: 75 mg\u002Fm²\u002Fday at bedtime (Days 1-21); MTX: 20 mg\u002Fm² IM weekly × 3 weeks.\\*Adjust doses to maintain WBC \\~3×10⁹\u002FL, ANC 1.0-1.5×10⁹\u002FL.\\*",[9],[51],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":55},"Tao Wang, Dr.","CONTACT","13835175119","wangtao99699@163.com",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Taiyuan","Shanxi","030000","China","CN",{"type":65,"coordinates":66},"Point",[67,68],112.56028,37.86944,{"lat":68,"lon":67},[71],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":55},{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100597489","phase-2-multicenter-study-of-combined-chemotherapy-and-transplantation-for-adult-all-100597489",false,"NCT07059156","Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age: 18 to 60 years；\n2. Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts\u002Fimmature lymphocytes in bone marrow (Note: Patients with \\\u003C20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；\n3. ECOG Performance Status: 0-2\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage\n2. Pregnancy\n3. Psychiatric disorders or other conditions compromising protocol compliance\n4. Severe cardiac arrhythmia with ECG abnormalities (QTc \\>500 ms)","ALL","18 Years","60 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88,89],"PHASE2","PHASE3","This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.",[92],"Acute Lymphoblastic Leukemia, Adult","2025-07-01",{"date":95,"type":96},"2025-07-10","ACTUAL",{"date":98,"type":96},"2025-06-01",{"date":100,"type":85},"2027-07",{"name":5,"class":6},1]