RecruitingPhase 2NCT06936943

ONO-4538 Study in Patients With Richter's Transformation

A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

14 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

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

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Interventions

DRUGONO-4538

every 4 weeks


Locations(10)

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Kyusyu University Hospital

Fukuoka, Fukuoka, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan

Kindai University Hospital

Ōsaka-sayama, Osaka, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō-Ku, Tokyo, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06936943


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