Relapsed or Refractory Diffuse Large B-cell LymphomaPhase 1NCT04049825
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
A Phase 1 study testing OPB-111077 in people with Relapsed or Refractory Diffuse Large B-cell Lymphoma, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Relapsed or Refractory Diffuse Large B-cell Lymphoma
- What is being tested?
- OPB-111077
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 22 Nov 2019to 19 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
- Being tested
- OPB-111077
- Medical subject headings
- Recurrence, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-111077Drug
OPB-111077+bendamustine
OPB-111077Drug
OPB-111077+rituximab+bendamustine
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Stage | Experimental | 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. Receives: Drug: OPB-111077 |
| Dose Expansion Stage | Experimental | 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 Receives: Drug: OPB-111077 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
The tolerability of OPB-111077 in combination with bendamustine and rituximab
Measured: 23days
Incidence of Adverse events(AEs)
Safety of OPB-111077 in combination with bendamustine and rituximab
Measured: Up to 3 years
Secondary outcomes (1)
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))
Measured: Last dose of study drug (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start22 Nov 2019
- Primary completion25 Mar 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049825
- Sponsor's protocol ID
- 317-102-00007
- Other IDs
- jRCT2080224718
- Status last verified
- Apr 2026
- First submitted
- 9 Jul 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The focus of this study is a rare disease.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04049825
- Acronym / sponsor ID
- 317-102-00007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Stage | Experimental | Drug: OPB-111077The 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. |
| Dose Expansion Stage | Experimental | Drug: OPB-1110774 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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>
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPB-111077OPB-111077+bendamustine | Drug | Dose Escalation Stage |
| OPB-111077OPB-111077+rituximab+bendamustine | Drug | Dose Expansion Stage |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 23days
The tolerability of OPB-111077 in combination with bendamustine and rituximab
Incidence of Adverse events(AEs)
Time frame: Up to 3 years
Safety of OPB-111077 in combination with bendamustine and rituximab
1 secondary outcome
Efficacy 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. The focus of this study is a rare disease.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobuhito Sanada study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPB-111077 in people with Relapsed or Refractory Diffuse Large B-cell Lymphoma, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 23days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.