[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490003":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":65,"centralContacts":69,"locations":74,"responsibleParty":96,"collaborators":29,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":29,"eligibilityCriteria":103,"healthyVolunteers":100,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":29,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric-inspired Regimen Combined With Venetoclax","EXPERIMENTAL","Induction therapy is administered as follows：Vincristine (VCR) 1.4 mg\u002Fm2 (maximum dose 2 mg) IV on D1,8,1,5,22; Daunorubicin (DNR) 30 mg\u002Fm2\u002Fday IV on D1-3; Cyclophosphamide (CTX) 1200 mg\u002Fm2 IV on D1,15; Pegaspargase 2500u\u002Fm2 IM on D5; Prednisone 1 mg\u002Fkg\u002Fd PO on D1-14, 0.5 mg\u002Fkg\u002Fd PO on D15-28; Venetoclax 100 mg PO on D6，200 mg on D7, 400mg on D8-14, All patients underwent bone marrow aspiration on day 14 during induction. Patients with bone marrow blasts ≥10% on day 14 of induction received 7 additional days of Venetoclax on day 15-22. Consolidation therapy is a combination of multi-drug pediatric-inspired regimen chemotherapy and Venetoclax. Maintenance therapy consisted of a monthly VMMP regimen (vincristine, mercaptopurine, methotrexate, prednisone) continuing until 3 years for male and 2.5 years for female patients.",[13,14,15,16,17,18,19,20,21,22],"Drug: Vincristine","Drug: Daunorubicin","Drug: Cyclophosphamide","Drug: Pegaspargase","Drug: Prednisone","Drug: Cytarabine","Drug: 6-mercaptopurine","Drug: Dexamethasone","Drug: Methotrexate","Drug: Venetoclax",[24,30,34,38,42,46,50,54,57,61],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Vincristine","Anti-tumor alkaloids",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Daunorubicin","Anthracycline",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Cyclophosphamide","Alkylating agent",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Pegaspargase","Polyethylene glycol (PEG) conjugated to L-asparaginase",[9],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Prednisone","Glucocorticoids",[9],{"type":25,"name":47,"description":48,"armGroupLabels":49,"otherNames":29},"Cytarabine","Pyrimidine antimetabolites",[9],{"type":25,"name":51,"description":52,"armGroupLabels":53,"otherNames":29},"6-mercaptopurine","Cell cycle-specific antitumor drug",[9],{"type":25,"name":55,"description":44,"armGroupLabels":56,"otherNames":29},"Dexamethasone",[9],{"type":25,"name":58,"description":59,"armGroupLabels":60,"otherNames":29},"Methotrexate","Antifolate antineoplastic drug",[9],{"type":25,"name":62,"description":63,"armGroupLabels":64,"otherNames":29},"Venetoclax","Selective inhibitor of B-cell lymphoma 2 (Bcl-2)",[9],[66],{"name":67,"affiliation":5,"role":68},"Jianxiang Wang, Dr","PRINCIPAL_INVESTIGATOR",[70],{"name":67,"role":71,"phone":72,"phoneExt":29,"email":73},"CONTACT","86-22-23909120","wangjx@ihcams.ac.cn",[75],{"facility":76,"status":77,"city":78,"state":29,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Institute of Hematology & Blood Diseases Hospital","RECRUITING","Tianjin","300020","China","CN",{"type":83,"coordinates":84},"Point",[85,86],117.17667,39.14222,{"lat":86,"lon":85},[89,92,93],{"name":90,"role":71,"phone":72,"phoneExt":29,"email":91},"Jianxiang Wang, Dr.","wangjx@medmail.com.cn",{"name":90,"role":68,"phone":29,"phoneExt":29,"email":29},{"name":94,"role":95,"phone":29,"phoneExt":29,"email":29},"Ying Wang, Dr.","SUB_INVESTIGATOR",{"type":97,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100490003","phase-2-pediatric-inspired-regimen-combined-with-venetoclax-for-adolescent-and-adult-patients-with-de-novo-philadelphia-chromosome-negative-acute-lymphoblastic-leukemia-100490003",false,"NCT05660473","Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* De novo and primary Ph\u002FBCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification\n* Age: 14 -60 years\n* Male or female\n* ECOG Performance Status 0-2\n* Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%;\n* Subject has provided written informed consent prior to any screening procedure\n\nExclusion Criteria:\n\n* Burkitt lymphoma\u002Fleukemia\n* Acute Leukemia of Ambiguous Lineage\n* Female patients who are pregnant or breast feeding\n* Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment\n* History of pancreatitis\n* Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \\>7.5%. Patients with preexisting, well-controlled diabetes are not excluded\n* History of active gastrointestinal bleeding within the last 6 months\n* History of arterial\u002Fvenous thrombosis within the last 6 months\n* Known HIV seropositivity\n* Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment","ALL","14 Years","60 Years",{"count":108,"type":109},100,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.",[115],"Precursor Cell Lymphoblastic Leukemia-Lymphoma",[117,118,119,120,62],"Philadelphia Chromosome-Negative","Acute Lymphoblastic Leukemia","Adolescent and Adult","Pediatric-inspired Regimen","2025-07-31",{"date":123,"type":124},"2025-08-01","ACTUAL",{"date":126,"type":124},"2022-08-01",{"date":128,"type":109},"2027-12-30",{"name":5,"class":6},1]