[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637052":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":51,"interventions":64,"overallOfficials":82,"centralContacts":87,"locations":93,"responsibleParty":106,"collaborators":43,"id":109,"slug":43,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":43,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":43,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":130,"whyStopped":43,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Composite Complete Response (CRc) rate after 2 cycles of induction therapy","CRc = CR + CRi; CR: bone marrow blasts \\\u003C5%, no extramedullary disease, no peripheral blasts, ANC ≥1.0×10⁹\u002FL, PLT ≥100×10⁹\u002FL; CRi: bone marrow blasts \\\u003C5%, no extramedullary disease, no peripheral blasts, incomplete hematologic recovery (ANC \\\u003C1.0×10⁹\u002FL or PLT \\\u003C100×10⁹\u002FL)","From randomization to 2 cycles of induction before consolidation therapy（100 days）",[14,17,21,25,29,32,35,39],{"measure":15,"description":16,"timeFrame":12},"MRD negativity rate","Bone marrow MRD \\\u003C0.01% detected by MFC",{"measure":18,"description":19,"timeFrame":20},"NGS-MRD negativity rate","NGS-MRD can not detected by IgH\u002FTCR NGS (NGS-based MRD will be incorporated as an exploratory complementary assay in patients with trackable clonotypic rearrangements at diagnosis)","From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up",{"measure":22,"description":23,"timeFrame":24},"CR1 bridge-to-allo-HSCT rate","Proportion of subjects who achieve CR\u002FCRi and successfully receive allo-HSCT within 2-3 cycles","Up to 6 months after enrollment",{"measure":26,"description":27,"timeFrame":28},"Overall Survival (OS)","Time from C1D1 to death from any cause; data censored at last follow-up for surviving subjects","From the time from randomization to time for up to 2 years",{"measure":30,"description":31,"timeFrame":28},"Event-Free Survival (EFS)","Time from C1D1 to first event (no CRc after 2 cycles, morphological\u002Fextramedullary relapse, disease progression, off-protocol anti-leukemia therapy, death from any cause); data censored at last follow-up for event-free subjects",{"measure":33,"description":34,"timeFrame":28},"Relapse-Free Survival (RFS)","Time from first CR\u002FCRi to relapse or death from any cause; relapse defined as bone marrow blasts ≥5%, extramedullary disease, peripheral blasts, or molecular MRD ≥10-⁴ in previously MRD-negative patients;data censored at last follow-up for relapse-free subjects",{"measure":36,"description":37,"timeFrame":38},"100-day Non-Relapse Mortality (100-day NRM)","Proportion of deaths from non-relapse causes within 100 days of diagnosis","Up to 100 days after initial MPAL diagnosis",{"measure":40,"description":41,"timeFrame":42},"Incidence of grade ≥3 adverse events (AEs)","Type, frequency and severity of grade ≥3 AEs graded by CTCAE v5.0","From treatment initiation to the end of Induction",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"NON_RANDOMIZED","PARALLEL","Two independent cohorts based on immunophenotype： Cohort A (T\u002FMyeloid MPAL) Cohort B (B\u002FMyeloid MPAL)","TREATMENT",{"masking":50,"maskingDescription":43,"whoMasked":43},"NONE",[52,59],{"label":53,"type":54,"description":55,"interventionNames":56},"Cohort A: T\u002FMyeloid MPAL","EXPERIMENTAL","Sonrotoclax: 40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; Azacitidine: 75mg\u002Fm² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles.\n\nPatients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.",[57,58],"Drug: BCL-2 indibitor","Drug: Azacitidine (AZA)",{"label":60,"type":54,"description":61,"interventionNames":62},"Cohort B: B\u002FMyeloid MPAL","Sonrotoclax: 40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; Azacitidine: 75mg\u002Fm² qd (D1-D7), subcutaneous injection; Blinatumomab: 9μg\u002Fday (D8-D14), 28μg\u002Fday (D15-D21), continuous intravenous infusion; 28-day cycle, ≥2 cycles.\n\nPatients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.",[57,58,63],"Drug: Blinatumomab",[65,72,78],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"DRUG","BCL-2 indibitor","Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral;\n\n* 2 cycles.",[53,60],[71],"Sonrotoclax",{"type":66,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Azacitidine (AZA)","75mg\u002Fm² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles",[53,60],[77],"Azacitidine",{"type":66,"name":79,"description":80,"armGroupLabels":81,"otherNames":43},"Blinatumomab","9μg\u002Fday (D8-D14), 28μg\u002Fday (D15-D21), continuous intravenous infusion",[60],[83],{"name":84,"affiliation":85,"role":86},"Suning Chen","The First Affiliated Hospital of Soochow University Principal Investigator","PRINCIPAL_INVESTIGATOR",[88],{"name":89,"role":90,"phone":91,"phoneExt":43,"email":92},"Jing Lu Doctor","CONTACT","86+0512-67781137","gloriajlu@163.com",[94],{"facility":5,"status":43,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":43},"Suzhou","Jiangsu","215000","China","CN",{"type":101,"coordinates":102},"Point",[103,104],120.59538,31.30408,{"lat":104,"lon":103},{"type":86,"investigatorFullName":107,"investigatorTitle":108,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Chen Suning","Doctor","100637052",false,"NCT07573670","A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia","A Prospective, Open-Label, Single-Arm, Two-Cohort Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Bcl-2 Inhibitor Combined With Azacitidine in the Treatment of Newly Diagnosed Mixed Phenotype Acute Leukemia","Inclusion Criteria:\n\n1. Aged 16 to 70 years old\n2. Newly diagnosed MPAL confirmed by the 2022 WHO\u002FICC classification criteria for hematopoietic and lymphoid neoplasms\n3. Previously untreated; use of glucocorticoids or hydroxyurea for ≤7 days to control tumor burden before enrollment is allowed, no other systemic anti-leukemia therapy\n4. ECOG performance status score 0-3\n5. No severe combined heart, brain, lung, liver or kidney disease, judged by the investigator to tolerate the study regimen\n6. Able to understand and voluntarily sign a written informed consent form\n\nExclusion Criteria:\n\n1. BCR::ABL-positive MPAL patients\n2. Presence of active, uncontrolled infection\n3. Known uncontrolled active central nervous system leukemia (CNSL)\n4. Life-threatening extramedullary disease requiring urgent radiotherapy or surgical debulking\n5. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \\\u003C40%\n6. Previous receipt of systemic anti-leukemia therapy\n7. Pregnant or lactating female subjects\n8. Judged by the investigator to be ineligible for the study for other reasons","ALL","16 Years","70 Years",{"count":119,"type":120},52,"ESTIMATED","INTERVENTIONAL",[123],"PHASE2","This is a prospective, open-label, single-arm, two-cohort Phase 2 clinical study designed to evaluate the efficacy and safety of Bcl-2 Inhibitor combined with azacitidine (with blinatumomab added in B\u002Fmyeloid subtype) in patients with newly diagnosed mixed phenotype acute leukemia (MPAL). Eligible subjects are divided into two cohorts based on immunophenotype: Cohort A (T\u002FMyeloid MPAL) receives Bcl-2 Inhibitor + azacitidine, and Cohort B (B\u002FMyeloid MPAL) receives Bcl-2 Inhibitor + azacitidine + blinatumomab. The treatment cycle is 28 days, with the primary efficacy endpoint assessed after 2 cycles of induction therapy. Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.The total enrollment period is 24 months, and all subjects will be followed up for at least 24 months from the first day of the first cycle (C1D1).\n\nThe primary objective is to evaluate the composite complete response (CRc) rate after 2 cycles of induction therapy , and the secondary objectives include evaluating measurable residual disease (MRD) negativity rate, bridge-to-allogeneic hematopoietic stem cell transplantation (allo-HSCT) rate in first complete response (CR1), overall survival(OS),Event-Free Survival(EFS),Relapse-Free Survival(RFS) and Safety.",[126],"Newly Diagnosed Mixed Phenotype Acute Leukemia",[128,129],"Newly diagnosed Mixed Phenotype Acute Leukemia","Bcl-2 inhibitor (Sonrotoclax)","NOT_YET_RECRUITING","2026-05-01",{"date":133,"type":134},"2026-05-07","ACTUAL",{"date":131,"type":120},{"date":137,"type":120},"2028-06-30",{"name":5,"class":6},1]