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

JRCT ID: jRCT2011210063

Registered date:21/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute Myeloid Leukemia
• Date of first enrollment: 17/01/2022
• Target sample size: 66
• Study type: Interventional
• Intervention(s): CC-486 Arm/Placebo Arm

Outcome(s)

• Primary Outcome: RFS

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Hayakawa Jin