{"entity":{"id":"nct04313881","kind":"trial","name":"Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)","aka":["ENHANCE"],"tldr":"A phase 3 trial of Magrolimab and Azacitidine in Myelodysplastic syndromes / neoplasms, run by Gilead Sciences, recorded as terminated on the registry.","summary":"Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) is a phase 3 interventional study registered as NCT04313881 by Gilead Sciences, with 539 participants recorded, started 2020-09-09 and due to reach its primary completion in 2023-09-13. Interventions recorded: Magrolimab, Azacitidine, Placebo. Conditions recorded: Myelodysplastic Syndromes.\n\nLinked to the drug Magrolimab because the registry names it among its interventions and Myelodysplastic syndromes / neoplasms among its conditions. Registry record only: no result has been read by an editor.","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04313881","url":"https://clinicaltrials.gov/study/NCT04313881"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["mds","mds-higher-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["magrolimab","azacitidine"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04313881","phase":"3","setting":"ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome","sponsor":"Gilead Sciences","started":"2020-09-09","startedType":"actual","yearReported":2024,"enrolled":539,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Complete Remission (CR)","primary":true,"unit":"%","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":21.3,"note":"95% CI 16.5 to 26.7; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":23.6,"note":"95% CI 18.7 to 29.1"}],"p":"0.5218","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"},{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":15.9,"note":"95% CI 13.3 to 19.5; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":18.6,"note":"95% CI 14.9 to 26.2"}],"hr":1.203,"ci":[0.947,1.528],"p":"0.1299","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":9,"note":"95% CI 8.3 to 10.9; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":9.4,"note":"95% CI 8.6 to 11.4"}],"hr":1.02,"ci":[0.802,1.297],"p":"0.8720","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Magrolimab + Azacitidine","n":268,"value":53.7,"note":"95% CI 47.6 to 59.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-21), not from a publication"},{"name":"Placebo + Azacitidine","n":271,"value":58.7,"note":"95% CI 52.6 to 64.6"}],"p":"0.2563","source":"https://clinicaltrials.gov/study/NCT04313881?tab=results"}]},"route":"/trials/nct04313881/","neighbours":{"cancer":[{"id":"mds-higher-risk","kind":"cancer","name":"Higher-risk myelodysplastic syndromes","route":"/cancers/mds-higher-risk/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"magrolimab","kind":"drug","name":"Magrolimab","route":"/drugs/magrolimab/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}]}}