臨床研究等提出・公開システム

Date of registration	Sept. 19, 2019
Last modified on	June. 24, 2023
Trial ID	jRCT2080224880

Scientific Title	A phase 2, multicenter, open-label, single-arm study of Valemetostat Tosylate (DS-3201b) in patients with relapsed or refractory adult T-cell leukemia/lymphoma
Public Title	Valemetostat Tosylate (DS-3201b) Phase 2 study in relapsed or refractory adult T-cell leukemia/lymphoma

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Phone Number	+81-3-6225-1111
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Phone Number	+81-3-6225-1111
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Nov. 21, 2019
Target Sample Size		25
Study Type		Interventional
Study Design	Study Design	Non-randomized, No control group, Multicenter, Open-label, PhaseII study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients with relapsed or refractory ATL who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen. - Aged >=20 years or older at the time of signing the informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. - At least 1 evaluable lesion - Subject who has defined laboratory criteria - Life expectancy >= 3 months.
	Exclusion Criteria	- A presence of central nervous system involvement at the time of screening tests. - Have poorly controlled complication (ex. Chronic congestive heart failure, unstable angina) - >= Grade 3 neuropathy. - QTcF >470 ms - Has an uncontrolled infection. - Subject who use of corticosteroids over 10 mg/day - Receipt of allogeneic hematopoietic stem cell transplantation. - History of, or concurrent, malignant tumors.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Adult T-cell leukemia/lymphoma: ATL
Intervention(s)		investigational material(s) Generic name etc : Valemetostat tosylate INN of investigational material : Valemetostat tosylate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Once a day, 200 mg, oral administration control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy ORR assessed by central evaluation organization
Secondary Outcome		safety efficacy pharmacokinetics pharmacodynamics pharmacogenomics other - ORR assessed by investigator/sub-investigator - Best response per tumor lesions - CR rate - TCR - TTR - DOR - PFS - OS - Safety - Pharmacokinetics - Pharmacodynamics

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Kagoshima University Hospital Institutional Review Board
Address of IRB	8-35-1 Sakuragaoka Kagoshima-city, Kagoshima, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 18, 2019

Secondary ID No.	NCT04102150
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194964
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	June. 24, 2023	(this page)	Changes
5	Sept. 28, 2022	Detail	Changes
4	Dec. 21, 2020	Detail	Changes
3	Dec. 12, 2019	Detail	Changes
2	Nov. 05, 2019	Detail	Changes
1	Sept. 20, 2019	Detail

List of change history