臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 18, 2023
Last modified on	April. 08, 2024
Trial ID	jRCT2071220092

Scientific Title	A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG) plus Best Supportive Care (BSC) versus Placebo plus BSC in Participants with IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Public Title	A Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG) plus BSC versus Placebo plus BSC in Participants with IPSS-R Low- or Intermediate-risk MDS (CA055026)

Contact for Scientific Queries	Name	Carlos Vigil
	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	Carlos Vigil
	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. 18, 2023
Actual date of first enrollment		April. 12, 2023
Target sample size		5
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	- Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification 17 of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5). - Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
	Exclusion Criteria	- Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy) - Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of <- 10% - Participants diagnosed with MDS with excess blasts-2 (MDS-EB2) - Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Myelodysplastic Syndrome
Intervention(s)		- Phase2-Oral azacitidine fix dose per protocol - Phase3: Arm A: Oral Azacitidine dose determined according to Phase 2 and Arm B: Pracebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- Phase2-Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0 - Phase2/3:Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
Secondary Outcome(s)		- Phase2/3:Number of participants who achieved Overall Response (OR) per IWG 2006 criteria within 6 cycles - Phase2/3:Number of participants who achieved 84-day packed red blood cells transfusion independence (pRBC-TI)

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Institutional review board of Japan Community Health care Organization Kyushu Hospital
Address	1-8-1 Kishinoura Yahatanishi-ku Kitakyushu-shi Fukuoka, Fukuoka
Telephone	+81-93-641-5111
E-Mail	kawakubo-mitsuaki@kyusyu.jcho.go.jp
Approval Status	Approval
Date of approval	Nov. 25, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05469737
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	US/Canada/Argentina/Australia/Korea Republic/Germany/France/Italy/Spain/Denmark/Switzerland/Czech Republic/Poland/Austria/Sweden/Israel/Turkey

History of Changes

No	Publication date
3	April. 08, 2024	(this page)	Changes
2	Jan. 10, 2024	Detail	Changes
1	Jan. 18, 2023	Detail

List of change history