[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631050":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":66,"locations":72,"responsibleParty":90,"collaborators":32,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":32,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":32,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":32,"overallStatus":75,"whyStopped":32,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemotherapy induction Arm","EXPERIMENTAL","Induction Regimen 1 (VDCLP+V): Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.\n\nPatients with either CD22-negative or CD22-positive B-ALL will receive this regimen.\n\nConsolidation Therapy: Based on the pediatric-inspired IH-2022 protocol, including Vincristine , Daunorubicin , Cyclophosphamide, Pegaspargase , Prednisone, Dexamethasone, Cytarabine, 6-Mercaptopurine , and High-Dose Methotrexate.\n\nImmunotherapy: Blinatumomab - optional, 1 to 4 cycles, starting post-induction, alternating with chemotherapy cycles.\n\nCAR-T Cell Therapy- optional: the third cycle.\n\nMaintenance Therapy: Consists of a monthly MM regimen and a VP plus Venetoclax regimen every 3 months.\n\nCNS Prophylaxis\n\nAllogeneic or autologous Hematopoietic Stem Cell Transplantation is considered for high-risk patients or those with positive MRD after induction.",[13,14,15,16,17,18,19,20],"Drug: VDCLP+V","Drug: Consolidation Therapy","Drug: Maintenance Therapy","Drug: Blinatumomab","Drug: Venetoclax","Procedure: CNS Prophylaxis","Procedure: CAR-T Cell Therapy","Procedure: Hematopoietic Stem Cell Transplantation (HSCT)",{"label":22,"type":10,"description":23,"interventionNames":24},"Immunotherapy induction Arm","Induction Regimen 2 (2VIP): Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.\n\nFor patients with CD22-positive B-ALL (≥20% blasts), especially those aged \\>55 years, the 2VIP regimen is recommended.\n\nConsolidation Therapy: Based on the pediatric-inspired IH-2022 protocol, including Vincristine , Daunorubicin , Cyclophosphamide, Pegaspargase , Prednisone, Dexamethasone, Cytarabine, 6-Mercaptopurine , and High-Dose Methotrexate.\n\nImmunotherapy: Blinatumomab - optional, 1 to 4 cycles, starting post-induction, alternating with chemotherapy cycles.\n\nCAR-T Cell Therapy- optional: the third cycle.\n\nMaintenance Therapy: Consists of a monthly MM regimen and a VP plus Venetoclax regimen every 3 months.\n\nCNS Prophylaxis\n\nAllogeneic or autologous Hematopoietic Stem Cell Transplantation is considered for high-risk patients or those with positive MRD after induction.",[25,14,15,16,17,18,19,20],"Drug: 2VIP",[27,33,37,41,45,49,53,58,62],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","VDCLP+V","Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"2VIP","Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.",[22],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Consolidation Therapy","Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.",[9,22],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Maintenance Therapy","Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.",[9,22],{"type":28,"name":46,"description":47,"armGroupLabels":48,"otherNames":32},"Blinatumomab","Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.",[9,22],{"type":28,"name":50,"description":51,"armGroupLabels":52,"otherNames":32},"Venetoclax","Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol",[9,22],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":32},"PROCEDURE","CNS Prophylaxis","Intrathecal injection (methotrexate, cytarabine, dexamethasone) for a total of at least 15 sessions. Prophylactic cranial irradiation (18 Gy) is an alternative for patients unable or unwilling to receive intrathecal injections.",[9,22],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":32},"CAR-T Cell Therapy","Preconditioning regimen with fludarabine and cyclophosphamide (FC) administered after the third course (second consolidation) for patients receiving CAR-T.",[9,22],{"type":54,"name":63,"description":64,"armGroupLabels":65,"otherNames":32},"Hematopoietic Stem Cell Transplantation (HSCT)","Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.",[9,22],[67],{"name":68,"role":69,"phone":70,"phoneExt":32,"email":71},"Hui Wei, Doctor","CONTACT","13132507161","weihui@ihcams.ac.cn",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Blood Diseases Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":82,"coordinates":83},"Point",[84,85],117.17667,39.14222,{"lat":85,"lon":84},[88],{"name":89,"role":69,"phone":32,"phoneExt":32,"email":32},"Hui Wei, MD",{"type":91,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100631050","pediatric-inspired-regimen-combined-with-venetoclax-and-immunotherapy-for-adult-ph-negative-acute-lymphoblastic-leukemia-100631050",false,"NCT07495631","Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia","A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated (except prednisone\u002Fhydroxyurea) Ph-negative ALL\n* Age ≥14 years, ≤60 years\n* ECOG performance status ≤2\n* Adequate organ function (liver, kidney, cardiac)\n* For patients of childbearing potential: use of effective contraception\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Burkitt leukemia\u002Flymphoma\n* Acute leukemia of ambiguous lineage\n* Pregnancy or lactation\n* Severe uncontrolled active infection\n* History of pancreatitis\n* Uncontrolled diabetes (HbA1c \\>7.5%)\n* Active gastrointestinal bleeding within 6 months\n* Arterial\u002Fvenous thrombosis within 6 months\n* Known HIV positivity\n* Severe psychiatric illness hindering compliance\n* Any other condition deemed unsuitable by the investigator","ALL","14 Years","60 Years",{"count":103,"type":104},43,"ESTIMATED","INTERVENTIONAL",[107],"NA","This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.",[110],"Acute Lymphoblastic Leukemia, Adult","2026-05-10",{"date":113,"type":114},"2026-05-13","ACTUAL",{"date":116,"type":114},"2026-04-08",{"date":118,"type":104},"2030-03-01",{"name":5,"class":6},1]