[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623144":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":28,"responsibleParty":41,"collaborators":20,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":20,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tocilizumab","EXPERIMENTAL","* Level 1: 4 mg\u002Fkg on Day 1 of cycles 1 to 3\n* Level 2: 6 mg\u002Fkg on Day 1 of cycles 1 to 3 (starting dose for the first cohort)\n* Level 3: 8 mg\u002Fkg on Day 1 of cycles 1 to 3\n* Level 4: 4 mg\u002Fkg on Days 1 and 15 of cycles 1 to 3",[13],"Drug: increase dose of tocilizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","increase dose of tocilizumab","Combining tocilizumab with the standard treatment of azacitidine and venetoclax",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Peterlin Pierre","CONTACT","02 40 08 74 018","+33","pierre.peterlin@chu-nantes.fr",[29],{"facility":30,"status":20,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":20},"CHU of Nantes","Nantes","44000","France","FR",{"type":36,"coordinates":37},"Point",[38,39],-1.55336,47.21725,{"lat":39,"lon":38},{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100623144","phase-1-study-with-tocilizumab-in-combination-with-venetoclax-and-azacitidine-chemotherapy-in-patients-with-acute-myeloid-leukemia-100623144",false,"NCT07392814","Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia","Single-Center Phase 1 Study With Escalating Doses of Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia (AML). TOCIVENA","TOCIVENA","Inclusion Criteria:\n\n* First-line AML regardless of karyotype and molecular profile\n* ECOG \\\u003C= 3\n* Patient eligible for chemotherapy combining azacitidine and venetoclax\n* Informed consent\n* Liver function tests: transaminases \\\u003C 3x normal, bilirubin \\\u003C 1.5x normal\n* Creatinine clearance \\> 30 ml\u002Fmin\n\nExclusion Criteria:\n\n* LAM3\n* Patients eligible for intensive \"3+7\" treatment\n* Uncontrolled infection\n* Active and\u002For treated infection with Hep B, C, or HIV\n* No social security or other health insurance\n* Pregnant women or patients who cannot use contraception due to fertility\n* Breastfeeding women\n* Minors\n* Adults under guardianship, conservatorship, or legal protection\n* Hypersensitivity to any of the active substances or excipients (see SPCs)\n* Patients unable to understand spoken or written French","ALL","18 Years",{"count":54,"type":55},12,"ESTIMATED","INTERVENTIONAL",[58],"PHASE1","This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy.\n\nThe patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.",[61],"Leukemia Acute Myeloid - AML",[63,64,65],"Leukemia","IL6","tocilizumab","NOT_YET_RECRUITING","2026-02-12",{"date":69,"type":70},"2026-02-17","ACTUAL",{"date":72,"type":55},"2026-03-10",{"date":74,"type":55},"2030-07-10",{"name":5,"class":6},1]