[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630860":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":51,"locations":57,"responsibleParty":75,"collaborators":30,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":30,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":30,"enrollmentInfo":86,"targetDuration":30,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":30,"overallStatus":60,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,18],{"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 for 2 years. OVB maintenance therapy continues for at least 5 years.\n\nOptional Add-on 1: Patients may receive 1-4 cycles of blinatumomab starting from Cycle 4.\n\nOptional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4\n\nAllogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.",[13,14,15,16,17],"Drug: Olverembatinib","Drug: Blinatumomab","Drug: Chemotherapy Backbone Regimens","Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)","Drug: Inotuzumab ozogamicin",{"label":19,"type":20,"description":21,"interventionNames":22},"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 venetoclax for 2 years. Olverembatinib therapy for at least 5 years.\n\nOptional Add-on 1: Patients with financial means may receive 1-4 cycles of blinatumomab starting from Cycle 4.\n\nOptional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4.\n\nAllogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.",[13,23,14,15,16,17],"Drug: Venetoclax",[25,31,35,39,43,47],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9,19],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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.",[19],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Blinatumomab","CD19\u002FCD3 bispecific T-cell engager (BiTE). Optional add-on therapy 1.Start from 4 cycle.\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.",[9,19],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"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.",[9,19],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)","Recommended for patients with MRD ≥0.01% after two treatment blocks.",[9,19],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Inotuzumab ozogamicin","Optional add-on therapy 2. Start from 4 cycle. at a total dose of 2 mg per cycle. TKI should be discontinued 5 days prior to InO administration, and olverembatinib oral therapy should be resumed one week after InO administration. For patients who remain NGS MRD-positive after one cycle of InO, a repeat cycle of InO may be considered.\n\nNote: If 2 cycles given,cycle 9 are omitted.",[9,19],[52],{"name":53,"role":54,"phone":55,"phoneExt":30,"email":56},"Hui Wei, MD","CONTACT","13132507161","weihui@ihcams.ac.cn",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Blood Diseases Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":67,"coordinates":68},"Point",[69,70],117.17667,39.14222,{"lat":70,"lon":69},[73],{"name":53,"role":54,"phone":74,"phoneExt":30,"email":56},"86-13132507161",{"type":76,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"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":87,"type":88},110,"ESTIMATED","INTERVENTIONAL",[91],"NA","This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study consists of two integrated parts. The first part is a randomized controlled comparison to investigate the role of venetoclax, a BCL2 inhibitor, when added to a backbone of olverembatinib (a third-generation TKI) and reduced-intensity chemotherapy (VPVO regimen) during the first three cycles of induction\u002Fconsolidation therapy. The second part is a single-arm exploration of inotuzumab ozogamicin (InO) combined with TKI and chemotherapy as a consolidation strategy for patients who complete the 90-day primary endpoint assessment but do not receive blinatumomab, offering an alternative to blinatumomab-based regimens. The primary endpoint for the venetoclax part is the rate of BCR-ABL \\\u003C 0.01% at day 90. The primary endpoint for the InO consolidation part is modified event-free survival (EFS) from the start of InO treatment. Key secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of molecular and hematologic relapse, NGS MRD negativity rates, and safety profiles including cardiovascular events and SOS\u002FVOD. The study aims to enroll 110 patients in the initial phase and an additional 78 patients for the InO consolidation phase.",[94],"Ph+ ALL","2026-07-21",{"date":97,"type":98},"2026-07-23","ACTUAL",{"date":100,"type":98},"2026-04-10",{"date":102,"type":88},"2030-03-30",{"name":5,"class":6},1]