臨床研究等提出・公開システム

Scientific Title	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
Public Title	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)

Contact for Scientific Queries	Name	Hayakawa Jin
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Hayakawa Jin
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 20, 2022
Actual date of first enrollment		Jan. 17, 2022
Target sample size		66
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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 HRQoL
	Age Minimum	55age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acute Myeloid Leukemia
Intervention(s)		CC-486 Arm/Placebo Arm
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		RFS
Secondary Outcome(s)		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

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IRB of Aiiku Hospital
Address	25-2-1 Minami 4 jyo nishi, Chuo-ku, Sapporo-shi, Hokkaido
Telephone	+81-11-563-2211
E-Mail	asano.hiroshi213@eps.co.jp
Approval Status	Approval
Date of approval	Dec. 23, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history