{"entity":{"id":"nct03416179","kind":"trial","name":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia","aka":[],"tldr":"A phase 3 trial of Glasdegib, CPX-351, Azacitidine and Cytarabine in Leukaemia, run by Pfizer, completed.","summary":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia is a phase 3 interventional study registered as NCT03416179 by Pfizer, with 730 participants recorded, started 2018-04-20 and reaching its primary completion in 2020-06-05. Interventions recorded: glasdegib, daunorubicin + cytarabine, azacitidine, Placebo, Placebo, glasdegib, cytarabine, HSCT. Conditions recorded: Leukemia, Myeloid, Acute.\n\nLinked to the drug Glasdegib 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 NCT03416179","url":"https://clinicaltrials.gov/study/NCT03416179"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["leukaemia"],"sections":[],"technologies":[],"targets":[],"drugs":["glasdegib","cpx-351","azacitidine","cytarabine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03416179","phase":"3","setting":"A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","sponsor":"Pfizer","started":"2018-04-20","startedType":"actual","yearReported":2021,"enrolled":730,"enrolledBasis":"registry","outcomes":[{"endpoint":"Intensive Study: Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Intensive Study: Glasdegib + Cytarabine + Daunorubicin","n":201,"value":17.3,"note":"95% CI 15.2 to 18.5; Figures from the ClinicalTrials.gov results section (first posted 2021-06-25), not from a publication"},{"name":"Intensive Study: Placebo + Cytarabine + Daunorubicin","n":203,"value":20.4,"note":"95% CI 17.6 to NA"}],"hr":1.08,"ci":[0.755,1.532],"p":"0.6579","source":"https://clinicaltrials.gov/study/NCT03416179?tab=results"},{"endpoint":"Non-intensive Study: Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Non-intensive Study: Glasdegib + Azacitidine","n":163,"value":10.3,"note":"95% CI 7.7 to 12.4; Figures from the ClinicalTrials.gov results section (first posted 2021-06-25), not from a publication"},{"name":"Non-intensive Study: Placebo + Azacitidine","n":162,"value":10.6,"note":"95% CI 8.4 to 13.3"}],"hr":1.04,"ci":[0.775,1.388],"p":"0.5955","source":"https://clinicaltrials.gov/study/NCT03416179?tab=results"}]},"route":"/trials/nct03416179/","neighbours":{"cancer":[{"id":"leukaemia","kind":"cancer","name":"Leukaemia (all types)","route":"/cancers/leukaemia/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"cpx-351","kind":"drug","name":"CPX-351 (liposomal daunorubicin-cytarabine)","route":"/drugs/cpx-351/"},{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"glasdegib","kind":"drug","name":"Glasdegib","route":"/drugs/glasdegib/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}