[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455516":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":43,"responsibleParty":131,"collaborators":24,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":24,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":24,"enrollmentInfo":142,"targetDuration":24,"studyType":145,"phases":146,"briefSummary":149,"conditions":150,"keywords":24,"overallStatus":70,"whyStopped":24,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"AB Science","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AB8939","EXPERIMENTAL","AB8939 administered as a single agent",[13],"Drug: AB8939",{"label":15,"type":10,"description":16,"interventionNames":17},"AB8939 plus Venetoclax","AB8939 administered in combination with venetoclax",[13,18],"Drug: Venetoclax",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Intravenous injection (from an initial dose of 0.9 mg\u002Fm²)",[9,15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Venetoclax","the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Norbert Vey, MD","Institut Paoli Calmettes, Marseille, France","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Nicholas Short, MD","MD Anderson Cancer Center, Houston, Texas",[38],{"name":39,"role":40,"phone":41,"phoneExt":24,"email":42},"Clinical Study Coordinator","CONTACT","+33(0)147200014","clinical@ab-science.com",[44,58,68,79,89,97,105,110,115,123],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":24},"MD Anderson Cancer Center","NOT_YET_RECRUITING","Houston","Texas","77030","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-95.36327,29.76328,{"lat":56,"lon":55},{"facility":59,"status":46,"city":60,"state":24,"zip":24,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":24},"Institut Paoli Calmettes","Marseille","France","FR",{"type":53,"coordinates":64},[65,66],5.38107,43.29695,{"lat":66,"lon":65},{"facility":69,"status":70,"city":71,"state":24,"zip":24,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":24},"National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit","RECRUITING","Athens","Greece","GR",{"type":53,"coordinates":75},[76,77],23.72784,37.98376,{"lat":77,"lon":76},{"facility":80,"status":70,"city":81,"state":24,"zip":24,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":24},"General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)","Alicante","Spain","ES",{"type":53,"coordinates":85},[86,87],-0.48149,38.34517,{"lat":87,"lon":86},{"facility":90,"status":70,"city":91,"state":24,"zip":24,"country":82,"countryCode":83,"cosmosGeoPoint":92,"geoPoint":96,"contacts":24},"Hospital San Pedro de 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Navarra","Pamplona",{"type":53,"coordinates":119},[120,121],-1.64323,42.81687,{"lat":121,"lon":120},{"facility":124,"status":70,"city":125,"state":24,"zip":24,"country":82,"countryCode":83,"cosmosGeoPoint":126,"geoPoint":130,"contacts":24},"Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)","Seville",{"type":53,"coordinates":127},[128,129],-5.97317,37.38283,{"lat":129,"lon":128},{"type":132,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100455516","phase-1-ab8939-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100455516",false,"NCT05211570","AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1\u002F2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","DOSE ESCALATION STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.\n* ECOG performance status ≤ 1\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\nEXPANSION COHORT STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* ECOG performance status ≤ 2\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years",{"count":143,"type":144},78,"ESTIMATED","INTERVENTIONAL",[147,148],"PHASE1","PHASE2","The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.",[151,152,153],"Acute Myeloid Leukemia Refractory","Acute Myeloid Leukemia, in Relapse","Myelodysplastic Syndrome Acute Myeloid Leukemia","2025-09-29",{"date":156,"type":157},"2025-10-02","ACTUAL",{"date":159,"type":157},"2022-06-01",{"date":161,"type":144},"2026-12",{"name":5,"class":6},10]