A Study of Oral Azacitidine or Placebo with Best Supportive Care as Maintenance Therapy in Japanese Subjects with Acute Myeloid Leukemia in Complete Remission (CA055-005)
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- jRCT2011210063
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 66
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - RFS
- Secondary Outcome Measures
Name Time Method Safety/tolerability type, frequency, severity, and relationship of AEs to study treatments; physical examinations, vital signs; clinical laboratory evaluations, and concomitant medication/therapy
Participant-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D-5L
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.