臨床研究等提出・公開システム

Japanese

Date of registration	May. 21, 2023
Last modified on	Sept. 07, 2023
Trial ID	jRCT1021230006

Scientific Title	A multi-center retrospective observational study of effectiveness, safety and treatment status of tirabrutinib in relapsed or refractory pcnsl (ROSETTA) (ROSETTA Study)
Public Title	A multi-center retrospective observational study of effectiveness, safety and treatment status of tirabrutinib in relapsed or refractory pcnsl (ROSETTA) (ROSETTA Study)

Contact for Scientific Queries	Name	Nagane Motoo
	Affiliation	Kyorin University Faculty of Medicine
	Address	6-20-2, Shinkawa Mitaka-city, Tokyo
	Telephone	+81-422-47-5511
	E-mail	mnagane@ks.kyorin-u.ac.jp
Contact for Public Queries	Name	Tsutsumi Shoko
	Affiliation	Mebix, Inc.
	Address	10F. Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-4362-4504
	E-mail	ROSETTA@mebix.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 06, 2023
Actual date of first enrollment		April. 06, 2023
Target sample size		206
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients diagnosed with relapsed or refractory PCNSL and started initial treatment with tirabrutinib between November 1, 2020 and April 30, 2022, and who were enrolled in a Post Marketing Surveillance
	Exclusion Criteria	1. Patients with PCNSL who had not recieved drug therapy 2. Patients with metastasis outside the central nervous system, excluding intraocular, at the time of starting the first tirabrutinib treatment 3. Patients diagnosed with secondary central nervous system lymphoma (SCNSL) 4. Patients who had participated in clinical studies involving other interventions between the first PCNSL diagnosed and the start of the first tirabrutinib treatment. However, among patients who had participated in clinical research involving intervention, patients who recieved treatment within the indications of PCNSL treatment can be enrolled in this study. 5.Patients who weren't perscribed 480 mg of tirabrutinib once daily in fasted condition at the start of treatment
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Relapsed or refractory Primary CNS Lymphoma
Intervention(s)
Health Condition(s) Keyword		Primary CNS lymphoma
Intervention(s) Keyword
Health Condition(s) Code		D008228
Intervention(s) Code
Primary Outcome(s)		Overall Survival
Secondary Outcome(s)		BOR, TTR, TTP, OS subgroup analysis, PFS subgroup analysis, BOR subgroup analysis

Primary Sponsor	Kyorin University Faculty of Medicine

Source of Monetary Support / Secondary Sponsor	ONO PHAMACEUTICAL CO., LTD.
Secondary Sponsor	Applicable

Source of Monetary Support	ONO PHAMACEUTICAL CO., LTD.
Secondary Sponsor	Applicable

Name of Certified Review Board	Ethics Committee of Hirosaki University Graduate School of Medicine
Address	5 Zaifu-cho, Hirosaki-shi, Aomori
Telephone	+81-172-33-5111
E-Mail	rinri@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 27, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Sept. 07, 2023	(this page)	Changes
2	Sept. 06, 2023	Detail	Changes
1	May. 21, 2023	Detail

List of change history