ONO-4538 Study in Patients With Richter's Transformation
A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
2 other identifiers
interventional
14
1 country
10
Brief Summary
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2025
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2025
CompletedFirst Posted
Study publicly available on registry
April 20, 2025
CompletedStudy Start
First participant enrolled
November 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
February 13, 2026
February 1, 2026
3.7 years
April 13, 2025
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR) (Centralized assessment)
up to 4 years
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (1)
ONO-4538
EXPERIMENTALONO-4538 480 mg solution administered intravenously every 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Histological diagnosis of diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma(HL)-type Richter's transformation with a history of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- 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
You may not qualify if:
- Serious complications
- Active multiple cancers
- Active central nervous system (CNS) disease
- History of allogeneic hematopoietic stem cell transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Kyusyu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Central Study Contacts
North America Clinical Trial Support Desk
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2025
First Posted
April 20, 2025
Study Start
November 19, 2025
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2030
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share