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Clinical Trials/JPRN-jRCT2011210063
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.

Registry
who.int
Start Date
January 21, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hayakawa Jin

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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