臨床研究等提出・公開システム

Date of registration	June. 15, 2026
Last modified on	Sept. 14, 2026
Trial ID	jRCT1071260043

Scientific Title	A Multicenter, Prospective Observational Study to Evaluate the Efficacy and Safety of Mosunetuzumab Plus Polatuzumab Vedotin in Patients with Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma (W-JHS NHL04, SUNMOSTAR)
Public Title	A Multicenter, Prospective Observational Study to Evaluate the Efficacy and Safety of Mosunetuzumab Plus Polatuzumab Vedotin in Patients with Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma (W-JHS NHL04, SUNMOSTAR)

Contact for Scientific Queries	Name	Kato Koji
	Affiliation	Kyushu University Hospital
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city,Fukuoka
	Telephone	+81-92-642-5230
	E-mail	kato.koji.429@m.kyushu-u.ac.jp
Contact for Public Queries	Name	Kato Koji
	Affiliation	Kyushu University Hospital
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city,Fukuoka
	Telephone	+81-92-642-5315
	E-mail	kato.koji.429@m.kyushu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 15, 2026
Target sample size		300
Study Type		Observational
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) Patients scheduled to receive Mosun+Pola combination therapy as part of routine treatment for relapsed or refractory aggressive B-cell lymphoma, based on the latest electronic package inserts for mosnetuzumab and polatuzumab vedotin. The indications based on the latest electronic package inserts are as follows: Relapsed or refractory large B-cell lymphoma (diffuse large B-cell lymphoma, high-grade B-cell lymphoma) Relapsed or refractory follicular lymphoma (Grade 3B) 2) Patients who have received sufficient explanation about the content of this study, and have obtained written consent from the patient themselves. 3) Patients aged 18 years or older at the time of obtaining informed consent.
	Exclusion Criteria	Patients who meet the following criteria will be excluded from this clinical study: 1) Patients who, in the opinion of the principal investigator or subinvestigator, are not suitable for participation in this study.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Relapsed or refractory aggressive non-Hodgkin lymphoma
Primary Outcome(s)		overall survival (OS)
Secondary Outcome(s)		1) Progression free survival (PFS) 2) Overall response rate (ORR), Complete response rate (CRR) 3) End of treatment-overall response rate (EOT-ORR), End of treatment complete response rate (EOT-CRR) 4) Duration of response (DOR), Duration of complete response (DOCR) 5) Adverse Event incidence rate and severity 6) Interruption of treatment due to adverse events, dose reduction, relative dose intensity (RDI) 7) Subgroups analysis of efficacy and safety in elderly subgroup

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Clinical Research Network Fukuoka Ethics Commit tee
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Japan, Fukuoka
Telephone	+81-92-643-7171
E-Mail	mail@crnfukuoka.jp
Approval Status	Approval
Date of approval	June. 12, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Sept. 14, 2026	(this page)	Changes
4	Aug. 20, 2026	Detail	Changes
3	July. 31, 2026	Detail	Changes
2	June. 30, 2026	Detail	Changes
1	June. 15, 2026	Detail

List of change history