{"id":"gilteritinib-azacitidine-venetoclax","safety":{"commonSideEffects":[{"rate":null,"effect":"Myelosuppression/neutropenia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Nausea/vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL3301622","moleculeType":"Small molecule","molecularWeight":"552.72"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Gilteritinib is a selective FLT3 inhibitor that blocks proliferative signaling in FLT3-mutated AML. Azacitidine is a hypomethylating agent that restores normal gene expression and induces differentiation. Venetoclax is a BCL-2 inhibitor that promotes apoptosis by disrupting mitochondrial survival pathways. The combination targets multiple pathways implicated in AML pathogenesis and chemoresistance.","oneSentence":"This triple combination targets acute myeloid leukemia by inhibiting FLT3 signaling (gilteritinib), promoting DNA methylation-dependent differentiation (azacitidine), and blocking anti-apoptotic BCL-2 proteins (venetoclax).","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:13:56.205Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML), including FLT3-mutated disease"}]},"trialDetails":[{"nctId":"NCT06317649","phase":"PHASE2","title":"Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-09-27","conditions":"Acute Myeloid Leukemia","enrollment":147},{"nctId":"NCT05564390","phase":"PHASE2","title":"MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-06-18","conditions":"Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy","enrollment":2000},{"nctId":"NCT07407140","phase":"PHASE3","title":"VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-04-30","conditions":"AML, Adult","enrollment":300},{"nctId":"NCT04988555","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)","status":"RECRUITING","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2022-02-28","conditions":"Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, Multiple Myeloma","enrollment":606},{"nctId":"NCT06713837","phase":"PHASE3","title":"IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2025-02-27","conditions":"Acute Myeloid Leukemia, Relapse/Recurrence","enrollment":339},{"nctId":"NCT05520567","phase":"PHASE1, PHASE2","title":"A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2023-01-31","conditions":"Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia","enrollment":70},{"nctId":"NCT07425808","phase":"PHASE2, PHASE3","title":"FLT3-ITD Targeted Therapy in Fit AML Patients","status":"NOT_YET_RECRUITING","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2026-12-01","conditions":"AML (Acute Myeloid Leukemia)","enrollment":230},{"nctId":"NCT07259707","phase":"PHASE2","title":"Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML","status":"RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2026-01-25","conditions":"Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia","enrollment":25},{"nctId":"NCT03013998","phase":"PHASE1, PHASE2","title":"Study of Biomarker-Based Treatment of Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Beat AML, LLC","startDate":"2016-11","conditions":"Previously Untreated Relapsed Refractory Acute Myeloid Leukemia","enrollment":3000},{"nctId":"NCT05955261","phase":"PHASE2","title":"A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia","status":"SUSPENDED","sponsor":"St. Jude Children's Research Hospital","startDate":"2023-07-25","conditions":"Acute Myeloid Leukemia","enrollment":70},{"nctId":"NCT04140487","phase":"PHASE1, PHASE2","title":"Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-12-17","conditions":"Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm","enrollment":97},{"nctId":"NCT04777916","phase":"","title":"Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)","status":"RECRUITING","sponsor":"Acute Leukemia French Association","startDate":"2022-04-14","conditions":"Acute Myeloid Leukemia (AML)","enrollment":5000},{"nctId":"NCT06561880","phase":"PHASE1, PHASE2","title":"The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-10-08","conditions":"FLT3 Gene Mutation, AML","enrollment":36},{"nctId":"NCT07131059","phase":"NA","title":"MRD-positive AML Clinical Study","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-05-11","conditions":"AML, Adult","enrollment":120},{"nctId":"NCT06265545","phase":"NA","title":"Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-02-22","conditions":"AML, Refractory, Relapsed","enrollment":120},{"nctId":"NCT03680677","phase":"","title":"Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies","status":"RECRUITING","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2018-09-21","conditions":"Leukemia, Acute, MDS","enrollment":20},{"nctId":"NCT06696183","phase":"PHASE2","title":"Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment","status":"RECRUITING","sponsor":"Technische Universität Dresden","startDate":"2025-04-25","conditions":"AML - Acute Myeloid Leukemia","enrollment":60},{"nctId":"NCT05177731","phase":"PHASE3","title":"Venetoclax + Decitabine vs. \"7+3\" Induction Chemotherapy in Young AML","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chen Suning","startDate":"2022-03-01","conditions":"AML, Adult, Chemotherapy Effect","enrollment":188},{"nctId":"NCT04336982","phase":"PHASE1","title":"A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia","status":"TERMINATED","sponsor":"Celgene","startDate":"2020-08-05","conditions":"Leukemia, Myeloid, Acute","enrollment":22},{"nctId":"NCT04655391","phase":"PHASE1","title":"Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation","status":"WITHDRAWN","sponsor":"City of Hope Medical Center","startDate":"2022-06-25","conditions":"Recurrent Acute Myeloid Leukemia","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Gilteritinib + Azacitidine + Venetoclax","genericName":"Gilteritinib + Azacitidine + Venetoclax","companyName":"Institute of Hematology & Blood Diseases Hospital, China","companyId":"institute-of-hematology-blood-diseases-hospital-china","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This triple combination targets acute myeloid leukemia by inhibiting FLT3 signaling (gilteritinib), promoting DNA methylation-dependent differentiation (azacitidine), and blocking anti-apoptotic BCL-2 proteins (venetoclax). Used for Acute myeloid leukemia (AML), including FLT3-mutated disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}