[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630860":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":52,"responsibleParty":70,"collaborators":29,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":29,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":29,"enrollmentInfo":81,"targetDuration":29,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":29,"overallStatus":55,"whyStopped":29,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Therapy (Chemotherapy + Olverembatinib)","ACTIVE_COMPARATOR","Patients receive a backbone of low-intensity chemotherapy combined with olverembatinib(OVB) .\n\nInduction : Vincristine D1,8,15,22; Prednisone D1-28; Olverembatinib D1-28；\n\nConsolidation 1 \\& 2: Olverembatinib D1-28; Prednisone D1-14；Vincristine D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.\n\nSubsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age .\n\nMaintenance therapy: MM and VP regimen with or without venetoclax according to the study groups for 2 years. OVB maintenance therapy continues for at least 5 years.\n\nOptional Add-on: Patients may receive 1-4 cycles of blinatumomab starting after Consolidation 1.If the patient undergoes CAR-T therapy, the following conditioning regimen will be administered in cycle 4.\n\nAllogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.",[13,14,15,16],"Drug: Olverembatinib","Drug: Blinatumomab","Drug: Chemotherapy Backbone Regimens","Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)",{"label":18,"type":19,"description":20,"interventionNames":21},"Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax)","EXPERIMENTAL","Patients receive the same backbone as the Control Arm plus the BCL2 inhibitor venetoclax for the first three treatment blocks.\n\nConsolidation 1 \\& 2 (OP, 4 weeks each): Olverembatinib (40mg every other day) D1-28; Prednisone D1-14；Vincristine (VCR) D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.\n\nSubsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age.\n\nMaintenance therapy:MM and VP regimen with or without venetoclax according to the study groups for 2 years. Olverembatinib therapy for at least 5 years.\n\nOptional Add-on: Patients with financial means may receive 1-4 cycles of blinatumomab starting after Consolidation 1.If the patient undergoes CAR-T therapy, the following conditioning regimen will be administered in cycle 4.\n\nAllogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.",[13,22,14,15,16],"Drug: Venetoclax",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Olverembatinib","Third-generation tyrosine kinase inhibitor (TKI) targeting BCR-ABL1, including T315I mutation.nduction \\& Consolidation: 40mg every other day.\n\nAfter achieving CMR: Reduced to 20mg every other day during maintenance.",[9,18],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Venetoclax","BCL-2 inhibitor. Used only in the experimental arm.Induction: Ramp-up: 100mg D1, 200mg D2, 400mg D3-28.\n\nConsolidation: 400mg D1-7.",[18],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Blinatumomab","CD19\u002FCD3 bispecific T-cell engager (BiTE). Optional add-on therapy.Start: After first consolidation.\n\nDuration: 1-4 cycles (each cycle = 28 days), intercalated with chemotherapy cycles.\n\nNote: If ≥3 cycles given,cycle 8 and 9 are omitted.",[9,18],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Chemotherapy Backbone Regimens","Induction (VPO\u002FVPVO): Vincristine + Prednisone + Olverembatinib (± Venetoclax).\n\nConsolidation (VOVP\u002FOVP): Vincristine +Olverembatinib + Prednisone (± Venetoclax).\n\nHD-MTX: High-dose methotrexate with leucovorin rescue in cycle 4,6,8.\n\nID-AraC: Intermediate-dose cytarabine in cycle 5,7,9.",[9,18],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)","Recommended for patients with MRD ≥0.01% after two treatment blocks.",[9,18],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Hui Wei, MD","CONTACT","13132507161","weihui@ihcams.ac.cn",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Blood Diseases Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":62,"coordinates":63},"Point",[64,65],117.17667,39.14222,{"lat":65,"lon":64},[68],{"name":48,"role":49,"phone":69,"phoneExt":29,"email":51},"86-13132507161",{"type":71,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100630860","chemotherapy-with-targeted-immunotherapy-for-newly-diagnosed-ph-all-100630860",false,"NCT07493161","Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL","Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study","Inclusion Criteria:\n\n* Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).\n* Age ≥ 14 years.\n* ECOG performance status ≤ 2.\n* Adequate organ function: Total bilirubin \\\u003C1.5x ULN; AST\u002FALT ≤2.5x ULN; Serum creatinine \\\u003C2x ULN; Cardiac enzymes \\\u003C2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \\>45%.\n* Male and female patients of childbearing potential must agree to use effective contraception.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.\n* Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).\n* Myocardial infarction within 12 months prior to enrollment; uncontrolled\u002Funstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.\n* Uncontrolled active severe infection.\n* Active psychiatric illness that may hinder treatment completion or informed consent.\n* Any other condition deemed unsuitable for the study by the investigator.","ALL","14 Years",{"count":82,"type":83},110,"ESTIMATED","INTERVENTIONAL",[86],"NA","This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All patients receive olverembatinib (a third-generation TKI) continuously and may receive up to 4 cycles of blinatumomab starting from the fourth cycle. The primary endpoint is the rate of BCR::ABL1 ≤0.01% at 90 days and event-free survival (EFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), molecular relapse rate, MRD negativity rate by NGS, and cardiovascular events.",[89],"Ph+ ALL","2026-05-10",{"date":92,"type":93},"2026-05-13","ACTUAL",{"date":95,"type":93},"2026-04-10",{"date":97,"type":83},"2030-03-30",{"name":5,"class":6},1]