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

Phase 2

• Conditions: Acute Myeloid Leukemia

• Registration Number: JPRN-jRCT2011210063
• Lead Sponsor: Hayakawa Jin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-21
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

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

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 HRQo

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RFS

Secondary Outcome Measures

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