NCT04049825CompletedPhase 1
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
A Phase 1, Multi-center, Open-label, Uncontrolled, Dose-escalation Trial to Evaluate the Safety of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 9 Jul 2019
- Start date
- 22 Nov 2019
- Primary completion date
- 25 Mar 2025
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04049825
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 22 Nov 2019 to the primary completion date, 25 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation
Other illness
- 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
Other
- Patients who were refractory to initial standard treatment
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yamagata University Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.