ONO-4538 Study in Patients With Richter's Transformation

Phase 2

Recruiting

• Conditions: Richter's Transformation
• Interventions: Drug: ONO-4538

• Registration Number: NCT06936943
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-13
• Study First Submitted QC: 2025-04-13
• Study First Posted: 2025-04-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-04
• Study Start: 2025-09
• Primary Completion: 2029-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Diagnosis of diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma (HL)-type Richter's transformation
• In the case of DLBCL-type Richter's transformation, refractory, intolerant or ineligible for treatment of DLBCL
• Patients with measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Expected to survive for 90 days or more

Exclusion Criteria

• Serious complications
• Active multiple cancers
• Active central nervous system (CNS) disease
• History of allogeneic hematopoietic stem cell transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-4538	ONO-4538	ONO-4538 480 mg solution administered intravenously every 4 weeks

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) (Centralized assessment)	up to 4 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR) (site investigator assessment)	up to 4 years
Overall survival (OS)	up to 4 years
Progression free survival (PFS)	up to 4 years
Disease control rate (DCR)	up to 4 years
Duration of response (DOR)	up to 4 years
Time to response (TTR)	up to 4 years
Best overall response (BOR)	up to 4 years
Change rate from baseline in the sum of diameters (SPD) of target lesions	up to 4 years
Best change rate from baseline in the sum of diameters (SPD) of target lesions	up to 4 years
Improvement rate of B symptom	up to 4 years
Safety (Adverse event)	Up to 30 days after the last dose

Trial Locations

Locations (3)

National Cancer Center Hospital; 🇯🇵 Chuo Ku, Tokyo, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kyusyu University Hospital; 🇯🇵 Fukuoka, Japan