Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Relapsed or Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
Eligibility Criteria
Inclusion
- 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
- \<Only for dose-expansion stage\>
- Patients who are pathologically diagnosed as CD20 positive lymphoma
- Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease
Exclusion
- 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)
- \<Only for dose-expansion stage\>
- \- Patients who have a history of rituximab administration and are intolerant to rituximab
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04049825
Start Date
November 22 2019
End Date
March 1 2025
Last Update
May 2 2024
Active Locations (1)
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1
Yamagata University Hospital
Yamagata, Japan