ONO-4538 Study in Patients With Richter's Transformation
February 12, 2026 updated by: Ono Pharmaceutical Co. Ltd
A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
Study Overview
Study Type
Interventional
Enrollment (Estimated)
14
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: North America Clinical Trial Support Desk
- Phone Number: +18665877745(Toll-Free)
- Email: clinical_trial@ono-pharma.com
Study Contact Backup
- Name: International Clinical Trial Support Desk
- Phone Number: +17162141777(Standard)
- Email: clinical_trial@ono-pharma.com
Study Locations
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan
- Recruiting
- Aichi Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 812-8582
- Recruiting
- Kyusyu University Hospital
-
-
Hiroshima
-
Hiroshima, Hiroshima, Japan
- Recruiting
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Recruiting
- Hokkaido University Hospital
-
-
Kyoto
-
Kyoto, Kyoto, Japan
- Recruiting
- Kyoto University Hospital
-
-
Miyagi
-
Sendai, Miyagi, Japan
- Recruiting
- Tohoku University Hospital
-
-
Niigata
-
Niigata, Niigata, Japan
- Recruiting
- Niigata University Medical & Dental Hospital
-
-
Osaka
-
Ōsaka-sayama, Osaka, Japan
- Recruiting
- Kindai University Hospital
-
-
Tokyo
-
Bunkyō-Ku, Tokyo, Japan
- Recruiting
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
-
Chuo Ku, Tokyo, Japan
- Recruiting
- National Cancer Center Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Serious complications
- Active multiple cancers
- Active central nervous system (CNS) disease
- History of allogeneic hematopoietic stem cell transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ONO-4538
ONO-4538 480 mg solution administered intravenously every 4 weeks
|
every 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response rate (ORR) (Centralized assessment)
Time Frame: up to 4 years
|
up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival (OS)
Time Frame: up to 4 years
|
up to 4 years
|
|
Disease control rate (DCR)
Time Frame: up to 4 years
|
up to 4 years
|
|
Safety (Adverse event)
Time Frame: Up to 30 days after the last dose
|
Up to 30 days after the last dose
|
|
Objective response rate (ORR) (site investigator assessment)
Time Frame: up to 4 years
|
up to 4 years
|
|
Progression free survival (PFS)
Time Frame: up to 4 years
|
up to 4 years
|
|
Duration of response (DOR)
Time Frame: up to 4 years
|
up to 4 years
|
|
Time to response (TTR)
Time Frame: up to 4 years
|
up to 4 years
|
|
Best overall response (BOR)
Time Frame: up to 4 years
|
up to 4 years
|
|
Change rate from baseline in the sum of diameters (SPD) of target lesions
Time Frame: up to 4 years
|
up to 4 years
|
|
Best change rate from baseline in the sum of diameters (SPD) of target lesions
Time Frame: up to 4 years
|
up to 4 years
|
|
Improvement rate of B symptom
Time Frame: up to 4 years
|
up to 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Project Leader, Ono Pharmaceutical Co. Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2025
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2030
Study Registration Dates
First Submitted
April 13, 2025
First Submitted That Met QC Criteria
April 13, 2025
First Posted (Actual)
April 20, 2025
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONO-4538-131
- jRCT2071250005 (Registry Identifier: Japan Registry of Clinical Trials)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.