ONO-4538 Study in Patients With Richter's Transformation

Last updated: February 12, 2026
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

ONO-4538

Clinical Study ID

NCT06936943
ONO-4538-131
jRCT2071250005
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological diagnosis of diffuse large B-cell lymphoma (DLBCL)-type or Hodgkinlymphoma(HL)-type Richter's transformation with a history of chronic lymphocyticleukemia (CLL) or small lymphocytic lymphoma (SLL)

  • In the case of DLBCL-type Richter's transformation, refractory, intolerant orineligible 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

Exclusion Criteria:

  • Serious complications

  • Active multiple cancers

  • Active central nervous system (CNS) disease

  • History of allogeneic hematopoietic stem cell transplantation

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: ONO-4538
Phase: 2
Study Start date:
November 19, 2025
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Aichi Cancer Center

    Nagoya 1856057, Aichi-ken 1865694
    Japan

    Active - Recruiting

  • Kyusyu University Hospital

    Fukuoka 1863967, Fukuoka 1863958 812-8582
    Japan

    Active - Recruiting

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima 1862415, Hiroshima 1862413
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo 2128295, Hokkaido 2130037 060-8648
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto 1857910, Kyoto 1857907
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai 2111149, Miyagi 2111888
    Japan

    Active - Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata 1855431, Niigata 1855429
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Ōsaka-sayama 11612568, Osaka 1853904
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō-Ku, Tokyo 1850144
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 1850144
    Japan

    Active - Recruiting

  • Kyusyu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

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