{"entity":{"id":"nct02677922","kind":"trial","name":"A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy","aka":[],"tldr":"A phase 1/2 trial of Azacitidine in acute myeloid leukaemia, run by Celgene, active and no longer recruiting.","summary":"A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy is a phase 1/2 interventional study registered as NCT02677922 by Celgene, with 130 participants enrolled, started 2016-06-03 and due to reach its primary completion in 2018-08-02. Interventions recorded: AG-120, Azacitidine and AG-221. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02677922","url":"https://clinicaltrials.gov/study/NCT02677922"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-idh"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02677922","phase":"1/2","setting":"A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy","sponsor":"Celgene","started":"2016-06-03","startedType":"actual","yearReported":2022,"enrolled":130,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate: Phase 2 (Randomized Stage)","primary":true,"unit":"%","arms":[{"name":"Phase 2 Randomized Stage: AG-221 (100mg) + AZA","n":68,"value":73.5,"note":"95% CI 61.4 to 83.5; Figures from the ClinicalTrials.gov results section (first posted 2022-11-22), not from a publication"},{"name":"Phase 2 Randomized Stage: AZA Monotherapy","n":33,"value":36.4,"note":"95% CI 20.4 to 54.9"}],"p":"0.0003","source":"https://clinicaltrials.gov/study/NCT02677922?tab=results"},{"endpoint":"Overall Survival: Phase 2 (Randomized Stage)","unit":"months","arms":[{"name":"Phase 2 Randomized Stage: AG-221 (100mg) + AZA","n":68,"value":22,"note":"95% CI 14.6 to NA; Figures from the ClinicalTrials.gov results section (first posted 2022-11-22), not from a publication"},{"name":"Phase 2 Randomized Stage: AZA Monotherapy","n":33,"value":22.3,"note":"95% CI 11.9 to NA"}],"p":"0.9720","source":"https://clinicaltrials.gov/study/NCT02677922?tab=results"}]},"route":"/trials/nct02677922/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-idh","kind":"cancer","name":"IDH1- and IDH2-mutated acute myeloid leukaemia","route":"/cancers/aml-idh/"}],"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/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}]}}