臨床研究等提出・公開システム

ONO-4538-131: A multicenter, open-label, uncontrolled study to evaluate the efficacy and safety of ONO-4538 in patients with Richter's transformation

ONO-4538-131: Phase II study of ONO-4538 in patients with Richter's transformation

Terasawa Tetsuji

Ono Pharmaceutical Co.,LTD

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

clinical_trial@ono-pharma.com

JP Clinical Trial Support Desk

Ono Pharmaceutical Co.,LTD

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

+81-120-278-120

clinical_trial@ono-pharma.com

Recruiting

April. 21, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1.Patients with a history of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and histologically digagnosed with diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma(HL)-type Richter's transformation
2.In the case of DLBCL-type Richter's transformation, patients who are refractory, intolerant or ineligible for treatment of DLBCL
3.Petients with measurable disease
4.Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5.Patients expected to survive for 90 days or more

1.Patient with serious complications
2.Patients with active multiple cancers
3.Patients with active central nervous system (CNS) disease
4.Patients with history of allogeneic hematopoietic stem cell transplantation

Both

Richter's transformation

Nivolumab (recombinant) is administered intravenously at 480mg once every 4weeks.

Objective response rate (ORR) (Centralized assessment)

Objective response rate (ORR) (Site investigator assesment)
Overall survival (OS)
Progression free survival (PFS)
Disease control rate (DCR)
Duration of response (DOR)
Time to response (TTR)
Best overall response (BOR)
Change rate from baseline in the sum of diameters (SPD) of target lesions
Best change rate from baseline in the sum of diameters (SPD) of target lesions
Safety (Adverse event)

+81-92-642-5774

Feb. 21, 2025

No

none