A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
19actual
Sites
31
Countries
Japan, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-17 | actual | When the study began enrolling |
| Primary completion | 2025-01-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-19 | actual | When this record first appeared on the registry |
| Results posted | 2026-02-11 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acute Myeloid Leukemia
Interventions
- Drug: Oral Azacitidine — also filed as CC-486, BMS-986345, Onureg
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFRecurrence Free Survival (RFS)
measured Approximately 17.7 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2023-06-27 · 6.1 MB · Prot_SAP_000.pdf
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