ONO-4538 Study in Patients With Richter's Transformation | NCT06936943

Studies
ONO-4538 Study in Patients With Richter's Transformation

NCT06936943

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Feb 13, 2026Actual

Enrollment

14Estimated

Phase

Phase 2

Conditions

Richter's Transformation

Interventions

ONO-4538

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
jRCT2071250005	Registry Identifier	Japan Registry of Clinical Trials

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2025Actual

Primary Completion Date

Jul 31, 2029Estimated

Completion Date

Jul 31, 2030Estimated

First Submitted Date

Apr 13, 2025

First Submission Date that Met QC Criteria

Apr 13, 2025

First Posted Date

Apr 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ONO-4538	Experimental	ONO-4538 480 mg solution administered intravenously every 4 weeks	Drug: ONO-4538

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-4538	Drug	every 4 weeks	ONO-4538	Nivolumab Opdivo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR) (site investigator assessment)		up to 4 years
Overall survival (OS)		up to 4 years
Progression free survival (PFS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
North America Clinical Trial Support Desk	Contact	+18665877745(Toll-Free)		clinical_trial@ono-pharma.com
International Clinical Trial Support Desk	Contact	+17162141777(Standard)		clinical_trial@ono-pharma.com

Overall Officials

Name	Affiliation	Role
Project Leader	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aichi Cancer Center	Recruiting	Nagoya	Aichi-ken		Japan
Kyusyu University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077594	Nivolumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

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Browse Branches

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