ONO-4538 treatment for Richter's transformation
Official title: A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
Run by Ono Pharmaceutical Co., Ltd. · NCT06936943 · Data updated 2026-11-12
This trial will test if the drug ONO-4538 works and is safe for people whose CLL/SLL has transformed into Richter's transformation (DLBCL- or Hodgkin-type).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 14 (estimated) |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 10 sites (Nagoya, Aichi-ken and 9 other locations) |
| Status | Recruiting |
| Started | November 19, 2025 |
| Main results expected | July 31, 2029 |
| Study ends | July 31, 2030 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT06936943 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with biopsy-confirmed DLBCL- or Hodgkin-type Richter's transformation from CLL/SLL who have measurable disease, ECOG 0–1, are expected to live at least 90 days, and—if DLBCL-type—are refractory, intolerant of, or ineligible for standard DLBCL treatment.
✕Probably not a fit
Patients with active CNS disease, concurrent active multiple cancers, serious uncontrolled complications, or prior allogeneic hematopoietic stem cell transplantation are excluded and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2 interventional trial testing ONO-4538 given to patients with histologically confirmed DLBCL-type or Hodgkin-type Richter's transformation arising from prior CLL/SLL. Eligible patients must have measurable disease, ECOG performance status 0–1, and for DLBCL-type disease be refractory, intolerant of, or ineligible for standard DLBCL therapy. Key exclusions include active CNS involvement, other active malignancies, serious comorbid complications, and prior allogeneic stem cell transplant; the study is sponsored by Ono Pharmaceutical and conducted at three centers in Japan. The study will monitor tumor response and safety outcomes to determine whether ONO-4538 produces meaningful anti-lymphoma activity in this population.
Why it matters
Potential benefit: If effective, ONO-4538 could offer an additional treatment option and potentially improve responses for patients with Richter's transformation who have few effective therapies.
How similar studies have gone: PD-1 pathway inhibitors (the class that includes ONO-4538) have shown strong activity in Hodgkin lymphoma and some activity in other B-cell lymphomas with limited case series suggesting possible benefit in Richter's transformation, so the approach has clinical precedent but is not yet established for this condition.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan Recruiting -
Kyusyu University Hospital
Fukuoka, Fukuoka, Japan Recruiting -
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, Japan Recruiting -
Hokkaido University Hospital
Sapporo, Hokkaido, Japan Recruiting -
Kyoto University Hospital
Kyoto, Kyoto, Japan Recruiting -
Tohoku University Hospital
Sendai, Miyagi, Japan Recruiting
Show 4 more locations
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Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan Recruiting -
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan Recruiting -
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan Recruiting -
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan Recruiting
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating Glofitamab Alone or with Other Treatments for Richter's Transformation
This study is testing if a new treatment called Glofitamab, alone or with other medications, can help people with Richter's Transformation from Chronic Lymphocytic Leukemia feel better.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.