Status:

RECRUITING

ONO-4538 Study in Patients With Richter's Transformation

Lead Sponsor:

Ono Pharmaceutical Co. Ltd

Conditions:

Richter's Transformation

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

November 19 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2030

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT06936943

Start Date

November 19 2025

End Date

July 31 2030

Last Update

December 23 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

2

Kyusyu University Hospital

Fukuoka, Fukuoka, Japan, 812-8582

3

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

4

Kyoto University Hospital

Kyoto, Kyoto, Japan