A Study of Oral Azacitidine or Placebo with Best Supportive Care as Maintenance Therapy in Japanese Subjects with Acute Myeloid Leukemia 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

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011210063

Enrollment

Registered

2022-01-21

Start date

2022-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

CC-486 Arm/Placebo Arm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To evaluate the efficacy of CC-486 as maintenance therapy by using RFS in Japanese participants with more than 55 years with AML, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy.

Exclusion criteria

Exclusion criteria: To determine the effect of CC-486 as maintenance therapy on OS, time to relapse from CR/CRi, and time to discontinuation from treatment To determine safety and tolerability To determine PK To determine the effect of CC-486 on HRQoL

Design outcomes

Primary

Measure	Time frame
RFS	—

Secondary

Measure	Time frame
OS Time to relapse from CR/CRi Time to discontinuation from treatment Safety/tolerability (type, frequency, severity, and relationship of AEs to study treatments; physical examinations, vital signs; clinical laboratory evaluations, and concomitant medication/therapy) PK parameters Participant-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D-5L	—

Contacts

Public ContactJin Hayakawa

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026