{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["gilteritinib","azacitidine","venetoclax"]],"indication":"newly diagnosed or relapsed/refractory FLT3-mutated acute myeloid leukemia","name":"NCT04140487","nct_id":"NCT04140487","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04140487. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles, and gilteritinib PO QD on days 1-28. Treatment of azacytidine and venetoclax repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Cycles of gilteritinib repeat every 28 days in the absence of disease progression or unacceptable toxicity.","label":"Treatment (azacitidine, venetoclax, gilteritinib)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-09-01","type":"ESTIMATED"},"conditions":["Recurrent Acute Myeloid Leukemia","Recurrent Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic/Myeloproliferative Neoplasm","Refractory Acute Myeloid Leukemia","Refractory Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic/Myeloproliferative Neoplasm"],"enrollment":{"count":97,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Azacitidine","otherNames":["5 AZC","5-AC","5-Azacytidine","5-AZC","Azacytidine","Azacytidine, 5-","Ladakamycin","Mylosar","Onureg","U-18496","Vidaza"],"type":"DRUG"},{"name":"Gilteritinib","otherNames":["ASP-2215","ASP2215"],"type":"DRUG"},{"name":"Venetoclax","otherNames":["ABT-0199","ABT-199","ABT199","GDC-0199","RG7601","Venclexta","Venclyxto"],"type":"DRUG"}],"last_update":"2026-10-06","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"A Phase I/II Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2028-09-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximum-tolerated dose (MTD) of gilteritinib (Phase I)","timeFrame":"Up to 28 days"},{"measure":"Overall response rate (OR) (Phase II)","timeFrame":"Up to 56 days (2 cycles)"}],"references":[{"citation":"Short NJ, Kantarjian HM, Daver NG, Azevedo RS, Karrar O, DiNardo CD, Kadia TM, Yilmaz M, Maroun MM, Hachem MCR, Borthakur G, Issa GC, Shpall EJ, Popat UR, Huang X, Qiao W, Nasr LF, Macaron W, Abramova R, Garcia-Manero G, Konopleva M, Ravandi F. Long-Term Outcomes of Azacitidine, Venetoclax and Gilteritinib in Newly Diagnosed FLT3-Mutated AML. Blood Adv. 2026 May 27:bloodadvances.2026019841. doi: 10.1182/bloodadvances.2026019841. Online ahead of print.","pmid":"42200455","type":"DERIVED"},{"citation":"Short NJ, Daver N, Dinardo CD, Kadia T, Nasr LF, Macaron W, Yilmaz M, Borthakur G, Montalban-Bravo G, Garcia-Manero G, Issa GC, Chien KS, Jabbour E, Nasnas C, Huang X, Qiao W, Matthews J, Stojanik CJ, Patel KP, Abramova R, Thankachan J, Konopleva M, Kantarjian H, Ravandi F. Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or Refractory FLT3-Mutated AML. J Clin Oncol. 2024 May 1;42(13):1499-1508. doi: 10.1200/JCO.23.01911. Epub 2024 Jan 26.","pmid":"38277619","type":"DERIVED"}],"start_date":{"date":"2019-12-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","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","url":"https://clinicaltrials.gov/study/NCT04140487"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04140487"}