臨床研究等提出・公開システム

Date of registration	June. 09, 2021
Last modified on	July. 03, 2024
Trial ID	jRCT2031210139

Scientific Title	ONO-7913-02: Multi-center, open-label phase 1 study of ONO-7913 (magrolimab) in combination with azacitidine in patients with MDS
Public Title	ONO-7913-02 : ONO-7913 Phase 1 Study

Contact for Scientific Queries	Name	Osawa Masahiro
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120626190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Center Information Medical
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka 618-8585, Japan
	Telephone	+81-120626190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Suspended

Anticipated date of first enrollment		June. 22, 2021
Actual date of first enrollment		Aug. 16, 2021
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with histological confirmation of MDS defined according to WHO classification, with an IPSS-R risk category of intermediate, high, or very high risk 2. Patients judged by the investigator or subinvestigator to be appropriate for treatment with azacitidine 3. Patients with ECOG Performance Status of 0 to 1
	Exclusion Criteria	1. Patients who are determined to undergo allogeneic hematopoietic stem cell transplantation 2. Patients previously treated with azacitidine 3. Patients with severe complication
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Myelodysplastic Syndrome (MDS)
Intervention(s)		Administration of ONO-7913 with Azacitidine
Primary Outcome(s)		Tolerability, safety

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	NTT Medical Center Tokyo Institutional Review Board
Address	5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
Telephone	+81-3-3448-6111
E-Mail	chiken-ml@east.ntt.co.jp
Approval Status	Approval
Date of approval	June. 15, 2021

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	July. 03, 2024	(this page)	Changes
5	June. 28, 2024	Detail	Changes
4	Aug. 09, 2023	Detail	Changes
3	Dec. 14, 2022	Detail	Changes
2	Dec. 02, 2021	Detail	Changes
1	June. 09, 2021	Detail

List of change history