臨床研究等提出・公開システム

Date of registration	Nov. 08, 2024
Last modified on	Oct. 06, 2025
Trial ID	jRCT2031240473

Scientific Title	33-505 : Special Drug Use-Results Survey of OPDIVO (Pediatric Patients with Recurrent or Refractory Classical Hodgkin Lymphoma)
Public Title	33-505 : Special Drug Use-Results Survey of OPDIVO

Contact for Scientific Queries	Name	Nakao Takafumi
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan
	Telephone	+81-6-6222-5501
	E-mail	pms_contact_ml@ono-pharma.com
Contact for Public Queries	Name	Nakao Takafumi
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan
	Telephone	+81-6-6222-5501
	E-mail	pms_contact_ml@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 27, 2021
Target sample size		20
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Pediatric patients with recurrent or refractory classical hodgkin lymphoma, who have recieved OPDIVO for the first time
	Exclusion Criteria	'Patients who have received OPDIVO previously
	Age Minimum	No limit
	Age Maximum	15age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Recurrent or Refractory Classical Hodgkin Lymphoma
Primary Outcome(s)		'[Safety] a) Occurrence status of adverse drug reactions and infections b) Adverse events

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Not being included in the items required by GPSP Ordinance, a central IRB is not in place. The study is planned to conduct an IRB at the study site as needed.
Address	none, Tokyo
Date of approval	Jan. 12, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 06, 2025	(this page)	Changes
1	Nov. 08, 2024	Detail

List of change history