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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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1071260043
Enrollment
300
Registered
2026-06-15
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory aggressive non-Hodgkin lymphoma

Interventions

None listed

Sponsors

Kato Koji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
overall survival (OS)

Secondary

MeasureTime frame
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

Contacts

Public ContactKoji Kato

Kyushu University Hospital

kato.koji.429@m.kyushu-u.ac.jp+81-92-642-5315

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026