ONO-4538 Study in Patients With Richter's Transformation
NCT ID: NCT06936943
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
14 participants
INTERVENTIONAL
2025-11-19
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ONO-4538
ONO-4538 480 mg solution administered intravenously every 4 weeks
ONO-4538
every 4 weeks
Interventions
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ONO-4538
every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active multiple cancers
* Active central nervous system (CNS) disease
* History of allogeneic hematopoietic stem cell transplantation
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Kyusyu University Hospital
Fukuoka, Fukuoka, 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
Countries
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Central Contacts
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North America Clinical Trial Support Desk
Role: CONTACT
Phone: +18665877745(Toll-Free)
Email: [email protected]
International Clinical Trial Support Desk
Role: CONTACT
Phone: +17162141777(Standard)
Email: [email protected]
Other Identifiers
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jRCT2071250005
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-4538-131
Identifier Type: -
Identifier Source: org_study_id