A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

Inclusion Criteria:

• Patients with a definite diagnosis of Diffuse large B-cell lymphoma(DLBCL)

• Patients who have received at least initial standard treatment

• Patients with measurable lesions (based on International Working Group [IWG] 2014 criteria)

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

• Patients who are pathologically diagnosed as CD20 positive lymphoma

• Patients who have a history of being treated with 1 to 3 regimens of previous chemotherapy for the underlying disease

Exclusion Criteria:

• Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation

• Patients who were refractory to initial standard treatment

• Patients who have a history of bendamustine administration and are intolerant to bendamustine

• Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma

• Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL)

• Patients who have a history of rituximab administration and are intolerant to rituximab