NCT05197426

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Oral Azacitidine	Specified dose on specified days
OTHER	Placebo	Specified dose of specified days

Timeline

• Start date: 2022-01-17
• Primary completion: 2025-01-27
• Completion: 2026-04-30
• First posted: 2022-01-19
• Last updated: 2026-02-11
• Results posted: 2026-02-11

Locations

31 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study