Description:
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
Clinical Trials /
A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
NCT04049825
Related Conditions:
- Diffuse Large B-Cell Lymphoma
Recruiting Status:
Recruiting
Phase:
Phase 1
Trial Eligibility
Document
Title
- Brief Title: A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL
- 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)
Clinical Trial IDs
- ORG STUDY ID: 317-102-00007
- NCT ID: NCT04049825
Conditions
- Relapsed or Refractory Diffuse Large B-cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| OPB-111077 | Dose Escalation Stage | |
| OPB-111077 | Dose Expansion Stage |
Purpose
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and
rituximab in patients with r/r DLBCL.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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. |
|
| 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 |
|
Eligibility Criteria
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 3 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
| Maximum Eligible Age: | 80 Years |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Dose-limiting toxicity (DLT) |
| Time Frame: | 23days |
| Safety Issue: | |
| Description: | The tolerability of OPB-111077 in combination with bendamustine and rituximab |
Secondary Outcome Measures
| Measure: | 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) |
| Safety Issue: | |
| Description: | 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)) |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Otsuka Pharmaceutical Co., Ltd. |
Last Updated
October 30, 2020
