[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444970":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":21,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":21,"overallStatus":38,"whyStopped":21,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Azacitidine and Venetoclax","EXPERIMENTAL","A treatment cycle is 28 days long.\n\nAzacitidine will be given by injection under the skin, once a day, for the first 6 days of every cycle.\n\nVenetoclax will be given orally, once a day, as follows at the discretion of their study doctors:\n\nCycle 1:\n\n* Day 1 - 100 mg\n* Day 2 - 200 mg\n* Days 3 to 28 - 400 mg\n\nCycle 2:\n\n* Participants with a response to the study drugs will continue taking 400 mg from Days 1 to 21, with no study drug from Days 22 to 28 during Cycle 2.\n* Participants who have not yet responded to the study drugs will continue taking 400 mg from Days 1 to 28 during Cycle 2.\n\nCycle 3 and subsequent cycles:\n\n* Participants with a response to the study drugs will continue to take 400 mg from Days 1 to 21, with no study drug from Days 22 to 28.\n* Participants whose disease has not worsened will continue taking 400 mg from Days 1 to 28.\n* Participants have not responded to the study drugs will be withdrawn from the study.",[13,14],"Drug: Azacitidine","Drug: Venetoclax",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Azacitidine","Azacitidine is a hypomethylating agent that works by activating certain genes in the body to help cells mature and to kill abnormal bone marrow cells.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Venetoclax","Venetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells.",[9],[27],{"name":28,"affiliation":29,"role":30},"Vikas Gupta, M.D.","Princess Margaret Cancer Centre","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","416-946-2885","vikas.gupta@uhn.ca",[37],{"facility":29,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-79.39864,43.70643,{"lat":48,"lon":47},[51,52],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":21},{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100444970","phase-2-study-of-venetoclax-and-azacitidine-in-advanced-bcr-abl-negative-myeloproliferative-neoplasms-100444970",false,"NCT05074355","Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms","Venetoclax and Azacitidine Combination Therapy for Patients With Accelerated or Blast Phase BCR-ABL Negative Myeloproliferative Neoplasm (VAAMP)","Inclusion Criteria:\n\n* Ability to voluntarily provide written informed consent.\n* Documented diagnosis per World Health Organization (WHO) 2016 criteria of BCR-ABL negative myeloproliferative neoplasms (MPN).\n* Documented MPN transformation to accelerated phase (AP) or blast phase (BP) without prior blast reduction therapy for their AP\u002FBP disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function.\n* Must practice at least one reliable method of birth-control starting at least on cycle 1 day 1 until at least 90 days after the last dose of study drug.\n* Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1.\n\nExclusion Criteria:\n\n* History of allogeneic stem cell transplant for MPN.\n* Previous treatment with venetoclax, navitoclax, azacytidine or other hypomethylating agents (HMA).\n* White blood cell count \\>25 x 10\\^9\u002FL.\n* Current enrollment in another interventional study.\n* Presence of any active uncontrolled infection such as bacterial or fungal infections progressing despite adequate antimicrobial treatment.\n* Myocardial infarction in the preceding 3 months.\n* Active human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) infection.\n* History of active malignancy in the previous 2 years.\n* Any psychiatric illness or social circumstances or significant co-morbid conditions that may compromise study participation.\n* Pregnant or breastfeeding women.\n* Patients with known central nervous system (CNS) involvement with acute myeloid leukemia (AML) or CNS extramedullary hematopoiesis.\n* Patients with t (15;17)\n* Patients who have received strong and\u002For moderate CYP3A inducers within 7 days prior to the initiation of study treatment.\n* Active COVID-19 infection.\n* History of prior blast-reduction therapy for AP\u002FBP-MPN.\n* Preceding history MDS, chronic myelomonocytic leukemia (CMML), and other myelodysplastic syndromes (MDS)\u002FMPN overlap syndromes.","ALL","18 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase BRC-ABL negative myeloproliferative neoplasms.",[72],"Myeloproliferative Neoplasm","2026-07-02",{"date":75,"type":76},"2026-07-06","ACTUAL",{"date":78,"type":76},"2023-11-08",{"date":80,"type":66},"2026-12-31",{"name":5,"class":6},1]