Trial · NCT04173533
Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT
NCT04173533, Phase 3, Completed, University of Birmingham
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT. Trials, record NCT04173533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04173533
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT
- NCT number
- NCT04173533
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 326 participants, actual
- Lead sponsor
- University of Birmingham
- Conditions
- Acute Myeloid Leukemia, Myelodysplasia
- Interventions
- Oral azacitidine, Matched placebo
- First posted
- 2019-11-22
- Last updated
- 2026-08-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse free survival (RFS) | 12 months | To determine RFS at one year from randomisation of oral azacitidine compared with placebo in patients undergoing allo-SCT for AML/MDS |
| Secondary | Overall survival (OS) | 12 and 24 months | OS at one and two years from randomisation of oral azacitidine compared with placebo |
| Secondary | Cumulative incidence of relapse (CIR) | 12 and 24 months | CIR at one and two years after treatment comparing oral azacitidine with placebo |
| Secondary | Non-relapse mortality (NRM) | Day 100 and 12 months | NRM at 100 days and 12 months after treatment comparing oral azacitidine with placebo |
| Secondary | Incidence of acute and chronic graft-versus-host disease (GVHD) | 24 months | Incidence of acute and chronic GVHD comparing oral azacitidine with placebo |
| Secondary | Time to early treatment discontinuation | 24 months | Time to early treatment discontinuation comparing oral azacitidine with placebo |
| Secondary | Safety (adverse events) | 24 months | Number of patients with adverse events on oral azacitidine compared with placebo |
| Secondary | Quality of Life (EORTC-QLQ-C30 and EQ-5D) | 24 months | QoL will be measured to compare oral azacitidine with placebo |
| Secondary | GVHD-free and relapse-free survival (GRFS) | 12 and 24 months | GRFS defined as time from date of randomisation to date of first event or death |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04173533
GET https://conductscience.org/api/trials/v1/NCT04173533/registered