A Phase 1 interventional study of OPB-111077 and OPB-111077 in Relapsed or Refractory Diffuse Large B-cell Lymphoma, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
\<Only for dose-expansion stage>
Exclusion Criteria:
\<Only for dose-expansion stage>
- Patients who have a history of rituximab administration and are intolerant to rituximab
The dose of OPB-111077 in the first cohort will be 200 mg/day, increasing as appropriate to 400 mg/day in the second cohort and then to 600 mg/day in the third cohort.
Drug: OPB-111077
4 days on and 3days off of 21-day cycles of OPB-111077 Day 1 of 21-days cycles of rituximab Day 2 and 3 of 21-day cycles of bendamustine
Drug: OPB-111077
OPB-111077+bendamustine
OPB-111077+rituximab+bendamustine
Dose-limiting toxicity (DLT)
The tolerability of OPB-111077 in combination with bendamustine and rituximab
Time frame: 23days
Incidence of Adverse events(AEs)
Safety of OPB-111077 in combination with bendamustine and rituximab
Time frame: Up to 3 years
Efficacy based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014))
* Percentage of Participants with Complete Response based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014)) * Percentage of Participants with Complete Response and Partial Response based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014))
Time frame: Last dose of study drug (up to 3 years)
Plan to share: No — The focus of this study is a rare disease.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Co., Ltd.