NCT00915252: AML-AZA: azacitidine with chemotherapy in older adults

NCT00915252 is the AML-AZA program studying azacitidine added to intensive chemotherapy in older adults with newly diagnosed acute myeloid leukemia. The final randomized publication is more informative than the earlier 12-patient feasibility pilot. 1 2

Müller-Tidow and colleagues reported 214 randomized patients, median age 70: 105 assigned to azacitidine plus chemotherapy and 109 to chemotherapy alone. Median event-free survival was six months in both groups (P=.96). Median overall survival was 15 versus 21 months (P=.35), and 30-day mortality was 6% versus 5% (P=.76). 2

The trial therefore did not demonstrate added event-free or overall-survival benefit from this azacitidine schedule in the unselected older population. The authors also raised toxicity concerns; a nonsignificant survival comparison should not be converted into either a proven survival harm or a benefit. 2

The 2012 pilot supplies historical feasibility and safety context. Its discussion of the then-ongoing program is not a current recruitment notice or a claim that a 2026 trial has just been paused. 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00915252. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00915252. Original registration; establishes the exact study identity and registered methods.

2. Müller-Tidow et al. (2016; online 2015). Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the Study Alliance Leukemia. Leukemia 30:555–561; DOI 10.1038/leu.2015.306; PMID 26522083. Final randomized outcomes — Müller-Tidow et al. (2016; online 2015). Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the…Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. SAL investigators (2012). Original 12-patient pilot report. PLOS ONE; DOI 10.1371/journal.pone.0052695. Earlier feasibility evidence, not the final randomized analysis — SAL investigators (2012). Original 12-patient pilot report. PLOS ONE; DOI 10.1371/journal.pone.0052695. Earlier feasibility evidence, not the final randomized analysis.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.