ONO-4538 Study in Patients With Richter's Transformation

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Richter's Transformation

Treatments: Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT06936943

ONO-4538-131

jRCT2071250005 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

ONO-4538

Experimental group

Description:

ONO-4538 480 mg solution administered intravenously every 4 weeks

Treatment:

Drug: ONO-4538