Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01757535) enrolled 472 adults with acute myeloid leukaemia (AML) who had achieved remission after initial treatment. Participants were randomly assigned to receive either oral azacitidine plus best supportive care (238 people) or a placebo plus best supportive care (234 people). The trial was measuring how long people lived overall, how long they went without their disease returning, and other related time points. The reported data shows that the estimated median overall survival — that is, the point at which half the participants in each group had died — was 24.7 months in the oral azacitidine group compared with 14.8 months in the placebo group. For relapse-free survival (the time before the disease came back or a person died, whichever came first), the reported median was 10.2 months in the oral azacitidine group and 4.8 months in the placebo group. The reported median time to relapse alone was 10.2 months versus 4.9 months, and the median time participants stayed on their assigned treatment was 14.6 months versus 6.9 months. On a fatigue questionnaire scored from 0 to 52 (higher scores meaning less fatigue), both groups reported a small decline from their starting score: minus 3.7 points in the oral azacitidine group and minus 2.5 points in the placebo group. Regarding side effects, the reported data shows that 235 of 236 treated participants in the oral azacitidine group and 233 of 233 in the placebo group experienced at least one treatment-emergent adverse event (an unwanted health event occurring during or shortly after treatment). Serious adverse events were reported in 113 people in the oral azacitidine group and 55 in the placebo group. Grade 3 or higher events — meaning severe or life-threatening reactions as classified by a standard medical scale — were reported in 22 people in the oral azacitidine group and 5 in the placebo group, though full breakdowns of all adverse event categories were not detailed further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37952982) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Leukaemia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 55 years of age or older (male or female)
- You have been newly diagnosed with a specific type of blood cancer called acute myeloid leukemia (AML), either appearing on its own or developing from a previous blood disorder
- Your AML has gone into first remission (meaning treatment has cleared the signs of cancer) after intensive chemotherapy, with or without follow-up treatment, within the last 4 months
- You are able to carry out some or all of your normal daily activities, ranging from fully active to partially confined to a bed or chair (confirm with trial site)
Who may not be able to join:
- Your AML has certain specific genetic changes or chromosomal abnormalities identified by laboratory testing (confirm with trial site for the specific types)
- You have previously had a bone marrow or stem cell transplant
- Your remission was achieved using a specific type of drug called a hypomethylating agent
- You have been diagnosed with another form of cancer within the last 12 months
- The leukemia has spread to your brain or spinal cord (central nervous system)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
13 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Kaplan-Meier (K-M) Estimate for Overall Survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.