{"preliminary_commentary":{"by_channel":{"x_thread":6,"podcast":4,"youtube":1,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01757535\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"QUAZAR AML-001","nct_id":"NCT01757535","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=quazar-aml-001-nct01757535. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"QUAZAR AML-001","arms":[{"description":"300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.","label":"Oral Azacitidine","type":"EXPERIMENTAL"},{"description":"Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.","label":"Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2024-06-18","type":"ACTUAL"},"conditions":["Leukemia, Myeloid, Acute"],"enrollment":{"count":472,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Oral Azacitidine","otherNames":["CC-486; Onureg®"],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2025-07-08","lead_sponsor":"Celgene","official_title":"A Phase 3, 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 Subjects With Acute Myeloid Leukemia in Complete Remission","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-07-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Kaplan-Meier (K-M) Estimate for Overall Survival (OS)","timeFrame":"Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants."}],"references":[{"citation":"Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.","pmid":"26785287","type":"BACKGROUND"},{"citation":"Ravandi F, Dohner H, Wei AH, Montesinos P, Pfeilstocker M, Papayannidis C, Lai Y, Wang K, See WL, de Menezes DL, Petrlik E, Prebet T, Roboz GJ. Survival outcomes in patients with acute myeloid leukaemia who received subsequent therapy for relapse in QUAZAR AML-001. Br J Haematol. 2024 Mar;204(3):877-886. doi: 10.1111/bjh.19202. Epub 2023 Nov 12.","pmid":"37952982","type":"DERIVED"},{"citation":"Wei AH, Roboz GJ, Dombret H, Dohner H, Schuh AC, Montesinos P, Selleslag D, Bondarenko SN, Prebet T, Lai Y, Skikne B, Beach CL, Ravandi F. Survival outcomes with oral azacitidine maintenance in patients with acute myeloid leukemia in remission by receipt of initial chemotherapy: subgroup analyses from the phase III QUAZAR AML-001 trial. Haematologica. 2023 Oct 1;108(10):2820-2825. doi: 10.3324/haematol.2022.282296. No abstract available.","pmid":"36951156","type":"DERIVED"},{"citation":"Dohner H, Wei AH, Roboz GJ, Montesinos P, Thol FR, Ravandi F, Dombret H, Porkka K, Sandhu I, Skikne B, See WL, Ugidos M, Risueno A, Chan ET, Thakurta A, Beach CL, Lopes de Menezes D. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacitidine. Blood. 2022 Oct 13;140(15):1674-1685. doi: 10.1182/blood.2022016293.","pmid":"35960871","type":"DERIVED"},{"citation":"Zhu J, Wu Q, Wang J, Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Expert Rev Hematol. 2022 Apr;15(4):375-382. doi: 10.1080/17474086.2022.2061456. Epub 2022 May 11.","pmid":"35437111","type":"DERIVED"},{"citation":"Roboz GJ, Ravandi F, Wei AH, Dombret H, Thol F, Voso MT, Schuh AC, Porkka K, La Torre I, Skikne B, Zhong J, Beach CL, Risueno A, Menezes DL, Ossenkoppele G, Dohner H. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status. Blood. 2022 Apr 7;139(14):2145-2155. doi: 10.1182/blood.2021013404.","pmid":"34995344","type":"DERIVED"},{"citation":"Ravandi F, Roboz GJ, Wei AH, Dohner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.","pmid":"34454540","type":"DERIVED"},{"citation":"Wei AH, Dohner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Cakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Cermak J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.","pmid":"33369355","type":"DERIVED"}],"start_date":{"date":"2013-04-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission","url":"https://clinicaltrials.gov/study/NCT01757535"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/quazar-aml-001-nct01757535"}