[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648755":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":100,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard treatment of FLT3 mutated AML","EXPERIMENTAL",null,[13],"Drug: Venetoclax in association with 3+7 and midostaurin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Venetoclax in association with 3+7 and midostaurin","(1) induction with daunorubicin 60 mg\u002Fm²\u002Fday for 3 days, cytarabine 200 mg\u002Fm²\u002Fday for 7 days and MIDO 50 mg x 2\u002Fday from D8 to D21, (2) consolidation with 3 courses of intermediate dose cytarabine 1-1.5 gr\u002Fm² x 2\u002Fday at D1, D2 and D3 and MIDO 50 mg x 2\u002Fday from D8 to D21 in 35-day cycles, and (3) a maintenance with MIDO 50 mg x 2\u002Fday from D1 to D28 in 28-day cycles for 12 cycles. VEN is a highly potent BCL-2 inhibitor, synergistic with cytarabine, anthracyclines, and tyrosine kinase inhibitors. In the current study we aim at harnessing this synergistic effect with standard chemotherapy (cytarabine, anthracyclines) and tyrosine kinase inhibitor (MIDO) during induction, consolidation and maintenance. Our strategy aims at determining the best schedule of combination during induction chemotherapy whereas we do not foresee specific safety issues during consolidation and maintenance strategy",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Pierre-Yves DUMAS, PU-PH","CONTACT","+33 5 57 65 65 11","pierre-yves.dumas@chubordeaux.fr",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Sarah BERTOLI","+33 5 31 15 62 69","bertoli.sarah@iuct-oncopole.fr",[31,48,60],{"facility":32,"status":11,"city":33,"state":11,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"CH de la Côte Basque","Bayonne","64100","France","FR",{"type":38,"coordinates":39},"Point",[40,41],-1.473,43.49316,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":11,"email":47},"Anne BANOS, Dr","+33 5 59 44 38 32","abanos@ch-cotebasque.fr",{"facility":49,"status":11,"city":50,"state":11,"zip":51,"country":35,"countryCode":36,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"CHU de Bordeaux - Hôpital haut-Lévêque","Pessac","33600",{"type":38,"coordinates":53},[54,55],-0.6324,44.80565,{"lat":55,"lon":54},[58],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":59},"pierre-yves.dumas@chu-bordeaux.fr",{"facility":61,"status":11,"city":62,"state":11,"zip":63,"country":35,"countryCode":36,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CHU de Toulouse","Toulouse","31059",{"type":38,"coordinates":65},[66,67],1.44367,43.60426,{"lat":67,"lon":66},[70],{"name":71,"role":23,"phone":28,"phoneExt":11,"email":29},"Sarah BERTOLI, Dr",{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648755","phase-1-venetoclax-in-association-with-37-and-midostaurin-in-flt3-mutated-acute-myeloid-leukemia-100648755",false,"NCT07726576","Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia","Phase 1\u002F2 Evaluating the Addition of Venetoclax to Standard 3+7 and Midostaurin Induction Treatment in Patients With FLT3-mutated Acute Myeloid Leukemia Eligible to Intensive Chemotherapy - MIDOVEN","MIDOVEN","Main inclusion criteria:\n\n1. Age ≥18 years and ≤70 years\n2. Newly diagnosed AML according to World Health Organization (WHO) 2022 classification\n3. Documented FLT3 gene mutation (-TKD D835 or I836 or -ITD or both) FLT3-ITD is assessed by DNA fragment analysis. Positivity is defined as an ITD\u002Fwt ratio of ≥ 0.05 (5%).\n\n   FLT3-TKD D835 or I836 is assessed by NGS. Positivity is defined as a VAF \\> 5%.\n4. Patient must be eligible for intensive chemotherapy.\n\nMain exclusion criteria:\n\n1. Prior treatment for AML or myelodysplastic (MDS) phase.\n2. Prior exposure to VEN or other BCL2 inhibitors\n3. AML secondary to prior hematological disorders, including myelodysplastic syndrome, myeloproliferative disorders and\u002For therapy-related AML.\n4. Acute promyelocytic leukemia, CBF-AML, Phi+ AML\n5. Significant active cardiac disease within 6 months prior to the start of study treatment or QTc interval using Fridericia's formula (QTcF) ≥ 450 msec.\n6. Cardiac ejection fraction \\\u003C45%","ALL","18 Years","70 Years",{"count":86,"type":87},41,"ESTIMATED","INTERVENTIONAL",[90,91],"PHASE1","PHASE2","Acute myeloid leukemia (AML) with FLT3 mutation accounts for 30% of patients and is associated with a poor prognosis. Because of the FLT3 mutation, a tyrosine kinase inhibitor, midostaurin (MIDO), is added to the standard treatment with daunorubicin and cytarabine, from D8 to D21 of induction and of each consolidation cycle, followed by one year of maintenance. Venetoclax (VEN), a BCL2 inhibitor, has revolutionized the management of AML patients ineligible for intensive chemotherapy, in combination with azacitidine or cytarabine. The investigators hypothesize that a four-drug induction regimen (daunorubicin+cytarabine+MIDO+VEN) will increase complete remission (CR) rate without measurable residual disease (MRD) and improve event free survival (EFS), relapse free survival (RFS) and overall survival (OS) of this subgroup of patients with unmet medical need.",[94],"Leukemia, Myeloid, Acute",[96,97,98,99],"Acute myeloid leukemia","FLT3 mutation","midostaurin","venetoclax","NOT_YET_RECRUITING","2026-07-21",{"date":103,"type":104},"2026-07-24","ACTUAL",{"date":106,"type":87},"2026-09",{"date":108,"type":87},"2031-12",{"name":5,"class":6},3]