Clinical trial · Interventional
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)
NCT04049825CI-TRIAL-00107664completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Diffuse Large B-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPB-111077 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Stage
- description
- 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.
- interventionNames
- Drug: OPB-111077
- type
- EXPERIMENTAL
- label
- Dose Expansion Stage
- description
- 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
- interventionNames
- Drug: OPB-111077
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 \<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 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) \<Only for dose-expansion stage\> \- Patients who have a history of rituximab administration and are intolerant to rituximab
References
Publications (0)
Data not yet available
No reference posted for this study.