{"entity":{"id":"nct03268954","kind":"trial","name":"Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)","aka":[],"tldr":"A phase 3 trial of Azacitidine and Pevonedistat in Leukaemia, run by Takeda, completed.","summary":"Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) is a phase 3 interventional study registered as NCT03268954 by Takeda, with 454 participants recorded, started 2017-11-28 and reaching its primary completion in 2021-05-28. Interventions recorded: Azacitidine, Pevonedistat. Conditions recorded: Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute.\n\nLinked to the drug Pevonedistat because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03268954","url":"https://clinicaltrials.gov/study/NCT03268954"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["azacitidine","pevonedistat"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03268954","phase":"3","setting":"A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia","sponsor":"Takeda","started":"2017-11-28","startedType":"actual","yearReported":2022,"enrolled":454,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-Free Survival (EFS)","primary":true,"unit":"months","arms":[{"name":"Azacitidine 75 mg/m^2","n":227,"value":15.7,"note":"95% CI 14.42 to 19.68; Figures from the ClinicalTrials.gov results section (first posted 2022-09-22), not from a publication"},{"name":"Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2","n":227,"value":17.7,"note":"95% CI 13.63 to 20.24"}],"hr":0.968,"ci":[0.757,1.238],"p":"0.557","source":"https://clinicaltrials.gov/study/NCT03268954?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Azacitidine 75 mg/m^2","n":227,"value":16.8,"note":"95% CI 14.92 to 20.11; Figures from the ClinicalTrials.gov results section (first posted 2022-09-22), not from a publication"},{"name":"Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2","n":227,"value":20.3,"note":"95% CI 17.97 to 22.60"}],"hr":0.888,"ci":[0.709,1.113],"p":"0.152","source":"https://clinicaltrials.gov/study/NCT03268954?tab=results"}]},"route":"/trials/nct03268954/","neighbours":{"cancer":[{"id":"leukaemia","kind":"cancer","name":"Leukaemia (all types)","route":"/cancers/leukaemia/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"pevonedistat","kind":"drug","name":"Pevonedistat","route":"/drugs/pevonedistat/"}],"company":[{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}]}}