ONO-4538 Study in Patients With Richter's Transformation
ConditionRichter's Transformation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.
About this trial
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Serious complications
Active multiple cancers
Active central nervous system (CNS) disease
History of allogeneic hematopoietic stem cell transplantation
Trial design
Design model
Single group
Treatments tested in this trial
ONO-4538
Drugevery 4 weeks
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: ONO-4538Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) (Centralized assessment)
Time frame
up to 4 yearsSecondary outcomes
1
Objective response rate (ORR) (site investigator assessment)
Time frame
up to 4 years2
Overall survival (OS)
Time frame
up to 4 years3
Progression free survival (PFS)
Time frame
up to 4 years4
Disease control rate (DCR)
Time frame
up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov