臨床研究等提出・公開システム

Date of registration	Jan. 19, 2022
Last modified on	July. 31, 2024
Trial ID	jRCT2041210129

Scientific Title	Phase Ib/II Study of the Combination of Tucidinostat and Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (ME2205-1)
Public Title	Phase Ib/II Study of the Combination of Tucidinostat and Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (ME2205-1)

Contact for Scientific Queries	Name	Hatake Kiyohiko
	Affiliation	Junwakai Medical Foundation Incorporated Sanno Medical Center
	Address	8-5-35, Akasaka, Minato-Ku, Tokyo
	Telephone	+81-3-3273-7346
	E-mail	clinical-trials@meiji.com
Contact for Public Queries	Name	Clinical Development Dept.
	Affiliation	Meiji Seika Pharma Co., Ltd.
	Address	2-4-16, Kyobashi, Chuo-ku, Tokyo
	Telephone	+81-3-3273-3746
	E-mail	clinical-trials@meiji.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 09, 2022
Actual date of first enrollment		May. 23, 2022
Target sample size		71
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) Part A: Patients with diagnosed B-NHL, Part B: Patients with diagnosed DLBCL 2) Patients who have relapsed or refractory following at least one systemic therapy 3) Patients who have had response to a previous treatment regimen that included anti CD20 therapy at least once 4) Patients who have normal systemic organ function
	Exclusion Criteria	1) Patients with known double hit/triple hit lymphoma 2) Patients with bulky disease 3) Patients with a history or findings of cardiac disorders 4) Patients with gastrointestinal disorders or dysphagia which could affect oral medicine administration and absorption 5) Patients with a history of clinically significant pulmonary disorders (including interstitial lung disease, pneumonitis, obstructive pulmonary disease, and bronchospasm) 6) Patients with a history of or complications of other malignancies that have not been in remission for at least the last 5 years (except some cases) 7) Patients who are deemed by the principal investigator or sub-investigator to be unsuitable for participation in the study due to significant clinical findings, abnormal laboratory results, psychiatric disorders, or other conditions that could affect the results of the study
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		B-cell Non-Hodgkin's Lymphoma
Intervention(s)		Patients will receive tucidinostat at 40 mg QD twice weekly with a 3 to 4 day interval between doses and rituximab at 375 mg/m^2 on Day 1 of each Cycle in 21 day treatment cycles
Primary Outcome(s)		ORR at 6 to 8 weeks after the last dose of rituximab

Primary Sponsor	Meiji Seika Pharma Co., Ltd.

Name of Certified Review Board	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Institutional Review Board
Address	2-9, Myokencho, Showa-ku, Nagoya-shi, Aichi
Telephone	+81-52-832-1121
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Yamagata University Hospital Institutional Review Board
Address	2-2-2, Idanishi, Yamagata-shi, Aichi
Telephone	+81-23-633-1122
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Chiba Cancer Center Institutional Review Board
Address	666-2 Nitonacho, Chuo-ku, Chiba-shi, Aichi
Telephone	+81-43-264-5431
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Shimane University Hospital Clinical Trial Review Board
Address	89-1, Enyacho, Izumo-shi, Aichi
Telephone	+81-853-23-2111
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Kobe City Medical Center General Hospital Institutional Review Board
Address	2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-shi, Aichi
Telephone	+81-78-302-4321
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Tokai University Hospital Institutional Review Board
Address	143 Shimokasuya, Isehara-shi, Aichi
Telephone	+81-463-93-1121
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Aomori Prefectural Central Hospital Institutional Review Board
Address	2-1-1 Higashitsukurimichi, Aomori-shi, Aichi
Telephone	+81-17-726-8111
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	The Cancer Institute Hospital of JFCR Institutional Review Board
Address	3-8-31 Ariake, Koto-ku, Aichi
Telephone	+81-3-3520-0111
E-Mail	clinical-trials@meiji.com
Approval Status	Approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Kanagawa Cancer Center Institutional Review Board
Address	2-3-2 Nakao, Asahi-ku, Yokohama-shi, Aichi
Telephone	+81-45-520-2222
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Okayama University Hospital Institutional Review Board
Address	2-5-1 Shikata-cho, Kitaku, Okayama-shi, Aichi
Telephone	+81-86-223-7151
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Matsuyama Red Cross Hospital Institutional Review Board
Address	1 Bunkyocho, Matsuyama-shi, Aichi
Telephone	+81-89-924-1111
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Kumamoto University Hospital Institutional Review Board
Address	1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Aichi
Telephone	+81-96-344-2111
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Matsumoto Medical Center Institutional Review Board
Address	2-20-30 Muraimatiminami, Matsumoto-shi, Aichi
Telephone	+81-263-58-4567
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Kyushu University Hospital Institutional Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Aichi
Telephone	+81-92-642-5774
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Name of Certified Review Board	Tohoku University Hospital
Address	1-1 Seiryomachi, Aoba-ku, Sendai-shi, Aichi
Telephone	+81-22-717-7000
E-Mail	clinical-trials@meiji.com
Approval Status	Not approval
Date of approval	Feb. 18, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 31, 2024	(this page)	Changes
2	June. 10, 2022	Detail	Changes
1	Jan. 19, 2022	Detail

List of change history