JPRN-jRCT2011210063
Active, not recruiting
Phase 2
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
Hayakawa Jin0 sites66 target enrollmentJanuary 21, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hayakawa Jin
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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