[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598984":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":80,"collaborators":29,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":29,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":29,"enrollmentInfo":91,"targetDuration":29,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":65,"whyStopped":29,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants fit for intensive therapy","EXPERIMENTAL","This cohort will include patients fit for intensive therapy.\n\nInduction phase:\n\nGenetically low-risk patients Venetoclax 100mg on Day 4, 200mg on Day 5, 400mg on Days 6-11 orally; Daunorubicin 60mg\u002Fm2 or idarubicin 12mg\u002Fm2 IV daily on Days 1-3; Cytarabine 100mg\u002Fm2 IV daily on Days 1-7. No more than two cycles. Continue to consolidation phase if achieving CR\u002FCRi.\n\nGenetically intermediate\u002Fhigh-risk patients Venetoclax 100mg on Day 1, 200mg on Day 2, 400 mg on Days 3-28 orally; Azacitidine 75mg\u002Fm2 SC daily on Days 1-7. 28 days per cycle, and no more than two cycles. Continue to consolidation phase if achieving CR\u002FCRi and refuse allogeneic HSCT.\n\nConsolidation phase:\n\nPatients \\\u003C 60 years Cytarabine 1.5g\u002Fm2 IV every 12 hours on Days 1, 2, 3; Venetoclax 400mg on Days 1-7. Infuse donor GPBMCs on Day 8. Totally 3-4 cycles.\n\nPatients ≥ 60 years Cytarabine 1g\u002Fm2 IV every 12 hours on Days 1, 2, 3; Venetoclax 400mg on Days 1-7. Infuse donor GPBMCs on Day 8. Totally 3-4 cycles.",[13,14,15,16,17,18],"Drug: Venetoclax","Drug: Azacitidine (AZA)","Drug: Daunorubicin","Drug: Idarubicin（IDA）","Drug: Cytarabine (Ara-C)","Biological: GPBMC infusion",{"label":20,"type":10,"description":21,"interventionNames":22},"Participants unfit for intensive therapy but fit for lower intensity therapy","This cohort will include patients unfit for intensive therapy but fit for lower intensity therapy at diagnosis according to Ferrara 2013 criteria.\n\nInduction phase:\n\nVenetoclax 100mg on Day 1, 200mg on Day 2, 400 mg on Days 3-28 orally; Azacitidine 75mg\u002Fm2 SC daily on Days 1-7. 28 days per cycle, and no more than two cycles. Re-evaluate unfitness and continue to consolidation phase if achieving CR\u002FCRi and refuse allogeneic HSCT.\n\nConsolidation phase:\n\nConvert to \"fit\" patients and \\\u003C 60 years Cytarabine 1.5g\u002Fm2 IV every 12 hours on Days 1, 2, 3; Venetoclax 400mg on Days 1-7. Infuse donor GPBMCs on Day 8. Totally 3-4 cycles.\n\nConvert to \"fit\" patients and ≥ 60 years Cytarabine 1g\u002Fm2 IV every 12 hours on Days 1, 2, 3; Venetoclax 400mg on Days 1-7. Infuse donor GPBMCs on Day 8. Totally 3-4 cycles.\n\nStill \"unfit\" patients Venetoclax 400 mg on Days 1-14 orally; Azacitidine 75mg\u002Fm2 SC daily on Days 1-7. Infuse donor GPBMCs on Day 15. 28 days per cycle until progression or untolerated.",[13,14,17,18],[24,30,34,38,41,44],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Venetoclax","Given PO",[9,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Azacitidine (AZA)","Given SC",[9,20],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Daunorubicin","Given IV",[9],{"type":25,"name":39,"description":36,"armGroupLabels":40,"otherNames":29},"Idarubicin（IDA）",[9],{"type":25,"name":42,"description":36,"armGroupLabels":43,"otherNames":29},"Cytarabine (Ara-C)",[9,20],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":29},"BIOLOGICAL","GPBMC infusion","HLA-mismatched donor GPBMC infusion",[9,20],[50],{"name":51,"affiliation":52,"role":53},"Bo Cai, MD","Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[55,59],{"name":51,"role":56,"phone":57,"phoneExt":29,"email":58},"CONTACT","+861066947168","caibo2008@163.com",{"name":60,"role":56,"phone":61,"phoneExt":29,"email":62},"Yangyang Lei, MD","+861066947180","942056176@qq.com",[64],{"facility":52,"status":65,"city":66,"state":29,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Beijing","100071","China","CN",{"type":71,"coordinates":72},"Point",[73,74],116.39723,39.9075,{"lat":74,"lon":73},[77,78,79],{"name":51,"role":56,"phone":57,"phoneExt":29,"email":58},{"name":60,"role":56,"phone":61,"phoneExt":29,"email":62},{"name":51,"role":53,"phone":29,"phoneExt":29,"email":29},{"type":81,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100598984","phase-2-venetoclax-containing-therapy-combined-with-microtransplant-for-newly-diagnosed-aml-100598984",false,"NCT07078591","Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML","Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Age \\>=18 years, male or female, non-limited by race or ethnicity.\n* No prior anti-acute leukemia treatment (including hypomethylators for leukemia or MDS) with the exception that prior hydroxyurea and\u002For leukapheresis are permitted.\n* Confirmed acute myeloid leukemia in accordance with WHO criteria with a WBC count \\\u003C 25 × 109\u002FL.\n* Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\\\u003C= 3 × upper limit of normal(ULN), and total bilirubin \\\u003C= 1.5 × ULN.\n* Adequate renal function including serum creatinine \\\u003C= 2 × ULN or CrCl\\>= 40mL\u002Fmin.\n* LVEF measured by echocardiogram is within the normal range (LVEF \\> 50%).\n* The subject must have one donor who is \\>= 18 years old and HLA matched at 0-7\u002F10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form.\n* Each subject (or his\u002Fher legal representatives) must sign the Informed Consent Form (ICF), indicating that he\u002Fshe understands the purpose and procedures of research, and is willing to participate in research.\n* Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and blast crisis.\n* Uncontrolled infection or hemorrhage.\n* Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.\n* Uncontrolled autoimmune disease or requiring immunosuppression treatment.\n* History of severe blood infusion reaction.\n* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.\n* Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.\n* Any major surgery within 4 weeks before enrollment.\n* Life-threatening illness other than AML or uncontrolled intercurrent illness.","ALL","18 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).",[99],"Acute Myeloid Leukemia",[101,102,103],"venetoclax","microtransplant","microtransplantation","2025-07-23",{"date":106,"type":107},"2025-07-28","ACTUAL",{"date":109,"type":107},"2025-06-20",{"date":111,"type":93},"2031-06",{"name":5,"class":6},1]