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NCT Number: NCT06936943

ONO-4538 Study in Patients With Richter's Transformation

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

Recruiting

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Key information

Conditions

Richter's Transformation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4538

Drug

every 4 weeks

Other names: Nivolumab, Opdivo

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

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 20, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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