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RecruitingNCT06936943Updated Feb 13, 2026

ONO-4538 Study in Patients With Richter's Transformation

A Phase 2 interventional study of ONO-4538 in Richter's Transformation, sponsored by Ono Pharmaceutical Co., Ltd.. Recruiting at 10 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation

02

Conditions studied

  • Richter's Transformation
03

In context

Lead sponsor

Ono Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Serious complications
  • Active multiple cancers
  • Active central nervous system (CNS) disease
  • History of allogeneic hematopoietic stem cell transplantation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    ONO-4538

    ONO-4538 480 mg solution administered intravenously every 4 weeks

    Drug: ONO-4538

Interventions

  • DrugONO-4538

    every 4 weeks

    Also known as: Nivolumab, Opdivo

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR) (Centralized assessment)

    Time frame: up to 4 years

Secondary outcomes

  1. Objective response rate (ORR) (site investigator assessment)

    Time frame: up to 4 years

  2. Overall survival (OS)

    Time frame: up to 4 years

  3. Progression free survival (PFS)

    Time frame: up to 4 years

  4. Disease control rate (DCR)

    Time frame: up to 4 years

  5. Duration of response (DOR)

    Time frame: up to 4 years

  6. Time to response (TTR)

    Time frame: up to 4 years

  7. Best overall response (BOR)

    Time frame: up to 4 years

  8. Change rate from baseline in the sum of diameters (SPD) of target lesions

    Time frame: up to 4 years

  9. Best change rate from baseline in the sum of diameters (SPD) of target lesions

    Time frame: up to 4 years

  10. Improvement rate of B symptom

    Time frame: up to 4 years

  11. Safety (Adverse event)

    Time frame: Up to 30 days after the last dose

07

Study locations

10 of 10 sites recruiting
  • Aichi Cancer Center
    Nagoya, Aichi-ken, Japan
    Recruiting
  • Kyusyu University Hospital
    Fukuoka, Fukuoka 812-8582, Japan
    Recruiting
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
    Hiroshima, Hiroshima, Japan
    Recruiting
  • Hokkaido University Hospital
    Sapporo, Hokkaido 060-8648, 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06936943
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 20, 2025
Start date
Nov 19, 2025
Primary completion
Jul 31, 2029 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Feb 13, 2026

Study contacts

North America Clinical Trial Support Desk
Contact
clinical_trial@ono-pharma.com
+18665877745(Toll-Free)
International Clinical Trial Support Desk
Contact
clinical_trial@ono-pharma.com
+17162141777(Standard)
Project Leader
study director · Ono Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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