臨床研究等提出・公開システム

Scientific Title	ONO-4059-13: A Multicenter, phase I, open-label, uncontrolled study of ONO-4059 in combination with rituximab, methotrexate, procarbazine, and vincristine (R-MPV) therapy for Untreated primary central nervous system lymphoma (PCNSL)
Public Title	Phase I study evaluating tolerability, safety, pharmacokinetics, and efficacy of combined ONO-4059 and R-MPV therapy for PCNSL

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Medical Information Center
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 05, 2024
Actual date of first enrollment		May. 17, 2024
Target sample size		20
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 diagnosed with PCNSL 2. Patients who have not received treatment for PCNSL in the past 3. Patients with ECOG Performance Status 0-2 4. Patients expected to survive for 6 months or more
	Exclusion Criteria	1.Patients with intraocular PCNSL without brain lesions 2.Patients are unable to swallow oral medications
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Primary central nervous system lymphoma
Intervention(s)		Concomitant administration of ONO-4059 and rituximab, methotrexate, procarbazine and vincristine (R-MPV) therapy
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Secondary Outcome(s)		-To evaluate the pharmacokinetics of ONO-4059 when ONO-4059 is administered in combination with R-MPV therapy in untreated PCNSL patients. -To investigate the efficacy of ONO-4059 in combination with R-MPV therapy in untreated PCNSL patients.

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kyushu University Hospital Institutional Review Board
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Fukuoka
Telephone
E-Mail
Approval Status	Approval
Date of approval	Feb. 27, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06541665
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history