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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2080224718 | Other Identifier | Japan Registry of Clinical Trials |
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To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPB-111077 | Drug | OPB-111077+bendamustine |
| |
| OPB-111077 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | The tolerability of OPB-111077 in combination with bendamustine and rituximab | 23days |
| Incidence of Adverse events(AEs) | Safety of OPB-111077 in combination with bendamustine and rituximab | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014)) |
|
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Inclusion Criteria:
<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
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| Name | Affiliation | Role |
|---|---|---|
| Nobuhito Sanada | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yamagata University Hospital | Yamagata | Japan |
The focus of this study is a rare disease.
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
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| Drug |
OPB-111077+rituximab+bendamustine |
|
| Last dose of study drug (up to 3 years) |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |