{"entity":{"id":"nct07007312","kind":"trial","name":"Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML","aka":[],"tldr":"A phase 3 trial of Ziftomenib, Venetoclax, Azacitidine, Daunorubicin and Cytarabine in acute myeloid leukaemia, run by Kura Oncology, Inc., now recruiting.","summary":"Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML is a phase 3 interventional study registered as NCT07007312 by Kura Oncology, Inc., with 1300 participants planned, started 2025-09-26 and due to reach its primary completion in 2031-11. Interventions recorded: Ziftomenib, Placebo, Venetoclax, Azacitidine (AZA), Daunorubicin and Cytarabine (Ara-C).","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07007312","url":"https://clinicaltrials.gov/study/NCT07007312"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-npm1-kmt2a"],"sections":[],"technologies":["bcl2-inhibitors","cytotoxic-chemotherapy","epigenetic-drugs","kinase-inhibitors"],"targets":[],"drugs":["ziftomenib","venetoclax","azacitidine","daunorubicin","cytarabine"],"companies":["kura-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07007312","phase":"3","setting":"Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia","sponsor":"Kura Oncology, Inc.","participation":[{"nct":"NCT07007312","source":"https://clinicaltrials.gov/study/NCT07007312","fetchedAt":"2026-10-07T16:55:21.080Z","studySha256":"c8f48b570be3728981617c4ffebefc7f3ecb1de93a9065883cc8856c88f94e87","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-07","leadSponsor":"Kura Oncology, Inc.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1300,"enrolmentType":"ESTIMATED","siteCount":122,"recruitingSiteCount":120,"countries":["Australia","Belgium","Canada","Czechia","France","Germany","Greece","Hungary","Italy","Philippines","Poland","Portugal","South Korea","Spain","Taiwan","United Kingdom","United States"]}],"started":"2025-09-26","startedType":"actual","enrolled":1300,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07007312/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-npm1-kmt2a","kind":"cancer","name":"NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia","route":"/cancers/aml-npm1-kmt2a/"}],"technology":[{"id":"bcl2-inhibitors","kind":"technology","name":"BCL-2 inhibitors","route":"/technologies/bcl2-inhibitors/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"daunorubicin","kind":"drug","name":"Daunorubicin","route":"/drugs/daunorubicin/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"},{"id":"ziftomenib","kind":"drug","name":"Ziftomenib","route":"/drugs/ziftomenib/"}],"company":[{"id":"kura-oncology","kind":"company","name":"Kura Oncology","route":"/companies/kura-oncology/"}]}}