臨床研究等提出・公開システム

Date of registration	Dec. 21, 2023
Last modified on	June. 14, 2024
Trial ID	jRCT2031230525

Scientific Title	EPKINLY Subcutaneous Injection General use-results surveillance (All case) of relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma: OBSC3013-39D-E
Public Title	EPKINLY Subcutaneous Injection General use-results surveillance (All case): OBSC3013-39D-E

Contact for Scientific Queries	Name	Genmab K.K. Drug safety and pharmacovigilance
	Affiliation	Genmab K.K.
	Address	7-1, AKASAKA 9-Chome, MINATO-Ku, TOKYO
	Telephone	+81-3-4494-8610
	E-mail	pvpmstoiawase@genmab.com
Contact for Public Queries	Name	Genmab K.K. Drug safety and pharmacovigilance
	Affiliation	Genmab K.K.
	Address	7-1, AKASAKA 9-Chome, MINATO-Ku, TOKYO
	Telephone	+81-3-4494-8610
	E-mail	pvpmstoiawase@genmab.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 21, 2023
Target sample size		250
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	All patients treated with EPKINLY
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma
Primary Outcome(s)		The incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenia, tumor lysis syndrome, and progressive multifocal leukoencephalopathy in post-marketing clinical use.
Secondary Outcome(s)		1: The timing of CRS onset. 2: The rate of CRS preventive measures. 3: The compliance with CRS and ICANS management guidance. 4: The incidence of all adverse events and adverse drug reactions that occurred in clinical use. Overall response rate as determined by Lugano Response Criteria for Malignant Lymphoma (2014)

Primary Sponsor	Genmab K.K.

Name of Certified Review Board	Not applicable
Address	Tokyo, Tokyo

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 14, 2024	(this page)	Changes
1	Dec. 21, 2023	Detail

List of change history