CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 19 enrolled
Drug / intervention
Oral Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05197426
NCT05197426Phase 2Active
CompareCT.gov

A Phase 2, 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 Japanese Subjects With Acute Myeloid Leukemia in Complete Remission

Bristol-Myers Squibb·interventional·Posted Jan 19, 2022·Updated Feb 11, 2026

In Brief

A Phase 2 clinical trial evaluating Oral Azacitidine and Placebo for Acute Myeloid Leukemia. Active but no longer recruiting, targeting 19 participants across 31 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesJapan, United States
Collaborators--

Timeline

Phase 2ActiveOverdue
20222023202420252026
First PostedJan 19, 2022
Enrollment StartJan 17, 2022
Primary CompletionJan 27, 2025
Study CompletionApr 30, 2026
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.5 years ago

Interventions

Oral Azacitidinedrug

Specified dose on specified days

Placeboother

Specified dose of specified days