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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06936943

Enrollment

Registered

2025-04-20

Start date

2025-11-19

Completion date

2030-07-31

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Richter's Transformation

Brief summary

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

Interventions

DRUGONO-4538

every 4 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) (Centralized assessment)	up to 4 years

Secondary

Measure	Time frame
Improvement rate of B symptom	up to 4 years
Safety (Adverse event)	Up to 30 days after the last dose
Progression free survival (PFS)	up to 4 years
Disease control rate (DCR)	up to 4 years
Duration of response (DOR)	up to 4 years
Time to response (TTR)	up to 4 years
Best overall response (BOR)	up to 4 years
Change rate from baseline in the sum of diameters (SPD) of target lesions	up to 4 years
Objective response rate (ORR) (site investigator assessment)	up to 4 years
Best change rate from baseline in the sum of diameters (SPD) of target lesions	up to 4 years
Overall survival (OS)	up to 4 years

Countries

Japan

Contacts

CONTACTNorth America Clinical Trial Support Desk

clinical_trial@ono-pharma.com+18665877745(Toll-Free)

CONTACTInternational Clinical Trial Support Desk

clinical_trial@ono-pharma.com+17162141777(Standard)

STUDY_DIRECTORProject Leader

Ono Pharmaceutical Co. Ltd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026