ONO-4538 treatment for Richter's transformation
A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
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 |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 10 sites (Nagoya, Aichi-ken and 9 other locations) |
| Trial ID | NCT06936943 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nagoya, Aichi-ken and 9 other locations
- 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)
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.