Richter's TransformationPhase 2NCT06936943
ONO-4538 Study in Patients With Richter's Transformation
A Phase 2 study testing ONO-4538 in people with Richter's Transformation, run by Ono Pharmaceutical Co., Ltd. at 10 sites in Japan.
Trial summary
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Richter's Transformation
- What is being tested?
- ONO-4538
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 10 sitesJapan
- Study dates
- 19 Nov 2025to 31 Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious complications
- Active multiple cancers
- Active central nervous system (CNS) disease
- History of allogeneic hematopoietic stem cell transplantation
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
10 sites in 1 country
Japan10 sites, 10 recruiting
- Recruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo
- Recruiting
Kyusyu University Hospital
Fukuoka, Fukuoka, 812-8582
- Recruiting
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto
- Recruiting
Aichi Cancer Center
Nagoya, Aichi-ken
- Recruiting
Niigata University Medical & Dental Hospital
Niigata, Niigata
- Recruiting
Kindai University Hospital
Ōsaka-sayama, Osaka
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
- Recruiting
Tohoku University Hospital
Sendai, Miyagi
About this study
Official title: 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
- Conditions
- Richter's Transformation
- Being tested
- ONO-4538
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
Also called Nivolumab, Opdivo
every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 | Experimental | ONO-4538 480 mg solution administered intravenously every 4 weeks Receives: Drug: ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) (Centralized assessment)
Measured: up to 4 years
Secondary outcomes (11)
Objective response rate (ORR) (site investigator assessment)
Measured: up to 4 years
Overall survival (OS)
Measured: up to 4 years
Progression free survival (PFS)
Measured: up to 4 years
Disease control rate (DCR)
Measured: up to 4 years
Duration of response (DOR)
Measured: up to 4 years
Time to response (TTR)
Measured: up to 4 years
Best overall response (BOR)
Measured: up to 4 years
Change rate from baseline in the sum of diameters (SPD) of target lesions
Measured: up to 4 years
Best change rate from baseline in the sum of diameters (SPD) of target lesions
Measured: up to 4 years
Improvement rate of B symptom
Measured: up to 4 years
Safety (Adverse event)
Measured: Up to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start19 Nov 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Richter's TransformationStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936943
- Sponsor's protocol ID
- ONO-4538-131
- Other IDs
- jRCT2071250005
- Status last verified
- Feb 2026
- First submitted
- 13 Apr 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
- ClinicalTrials.gov ID
- NCT06936943
- Acronym / sponsor ID
- ONO-4538-131
- Conditions
- Richter's Transformation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 | Experimental | Drug: ONO-4538ONO-4538 480 mg solution administered intravenously every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Serious complications
- Active multiple cancers
- Active central nervous system (CNS) disease
- History of allogeneic hematopoietic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538Also: Nivolumab, Opdivoevery 4 weeks | Drug | ONO-4538 |
Primary outcome
Objective response rate (ORR) (Centralized assessment)
Time frame: up to 4 years
11 secondary outcomes
Objective response rate (ORR) (site investigator assessment)
Time frame: up to 4 years
Overall survival (OS)
Time frame: up to 4 years
Progression free survival (PFS)
Time frame: up to 4 years
Disease control rate (DCR)
Time frame: up to 4 years
Duration of response (DOR)
Time frame: up to 4 years
Time to response (TTR)
Time frame: up to 4 years
Best overall response (BOR)
Time frame: up to 4 years
Change rate from baseline in the sum of diameters (SPD) of target lesions
Time frame: up to 4 years
Best change rate from baseline in the sum of diameters (SPD) of target lesions
Time frame: up to 4 years
Improvement rate of B symptom
Time frame: up to 4 years
Safety (Adverse event)
Time frame: Up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-4538 in people with Richter's Transformation, run by Ono Pharmaceutical Co., Ltd. at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (Centralized assessment) (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.