{"entity":{"id":"nct04023526","kind":"trial","name":"A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy","aka":["CULMINATE"],"tldr":"A phase 2 trial of Azacitidine and Cusatuzumab in acute myeloid leukaemia, run by OncoVerity, Inc., active and no longer recruiting.","summary":"A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy is a phase 2 interventional study registered as NCT04023526 by OncoVerity, Inc., with 103 participants enrolled, started 2019-07-29 and due to reach its primary completion in 2023-08-15. Interventions recorded: Azacitidine and Cusatuzumab. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04023526","url":"https://clinicaltrials.gov/study/NCT04023526"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine","cusatuzumab"],"companies":["oncoverity","argenx","johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04023526","phase":"2","setting":"A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy","sponsor":"OncoVerity, Inc.","started":"2019-07-29","startedType":"actual","yearReported":2024,"enrolled":103,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Complete Remission (CR)","primary":true,"unit":"%","arms":[{"name":"Cusatuzumab 10 mg/kg Plus Azacitidine","n":51,"value":11.76,"note":"95% CI 5.5 to 23.4; Figures from the ClinicalTrials.gov results section (first posted 2024-07-30), not from a publication"},{"name":"Cusatuzumab 20 mg/kg Plus Azacitidine","n":52,"value":26.92,"note":"95% CI 16.8 to 40.3"}],"source":"https://clinicaltrials.gov/study/NCT04023526?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Cusatuzumab 10 mg/kg Plus Azacitidine","n":51,"value":29.4,"note":"95% CI 18.7 to 43; Figures from the ClinicalTrials.gov results section (first posted 2024-07-30), not from a publication"},{"name":"Cusatuzumab 20 mg/kg Plus Azacitidine","n":52,"value":40.4,"note":"95% CI 28.2 to 53.9"}],"source":"https://clinicaltrials.gov/study/NCT04023526?tab=results"}]},"route":"/trials/nct04023526/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"}],"technology":[{"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/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"cusatuzumab","kind":"drug","name":"Cusatuzumab","route":"/drugs/cusatuzumab/"}],"company":[{"id":"argenx","kind":"company","name":"argenx","route":"/companies/argenx/"},{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"},{"id":"oncoverity","kind":"company","name":"OncoVerity","route":"/companies/oncoverity/"}]}}