{"entity":{"id":"nct05197426","kind":"trial","name":"A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission","aka":[],"tldr":"A phase 2 trial of Azacitidine in acute myeloid leukaemia, run by Bristol-Myers Squibb, active and no longer recruiting.","summary":"A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission is a phase 2 interventional study registered as NCT05197426 by Bristol-Myers Squibb, with 19 participants enrolled, started 2022-01-17 and due to reach its primary completion in 2025-01-27. Interventions recorded: Oral Azacitidine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT05197426","url":"https://clinicaltrials.gov/study/NCT05197426"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytotoxic-chemotherapy","epigenetic-drugs"],"targets":[],"drugs":["azacitidine"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05197426","phase":"2","setting":"A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission","sponsor":"Bristol-Myers Squibb","started":"2022-01-17","startedType":"actual","yearReported":2026,"enrolled":19,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence Free Survival (RFS)","primary":true,"unit":"months","arms":[{"name":"Treatment 1","n":12,"note":"Insufficient number of participants with events to calculate via KM methodology; Figures from the ClinicalTrials.gov results section (first posted 2026-02-11), not from a publication"},{"name":"Treatment 2","n":7,"value":7.4,"note":"range 1.4 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05197426?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Treatment 1","n":12,"note":"Insufficient number of participants with events to calculate via KM methodology; Figures from the ClinicalTrials.gov results section (first posted 2026-02-11), not from a publication"},{"name":"Treatment 2","n":7,"value":15.1,"note":"range 12.3 to NA"}],"source":"https://clinicaltrials.gov/study/NCT05197426?tab=results"}]},"route":"/trials/nct05197426/","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/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}]}}