Relapsed or Refractory Diffuse Large B-cell Lymphoma
Conditions
Brief summary
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
Interventions
DRUGOPB-111077
OPB-111077+bendamustine
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | 23days | The tolerability of OPB-111077 in combination with bendamustine and rituximab |
| Incidence of Adverse events(AEs) | Up to 3 years | Safety of OPB-111077 in combination with bendamustine and rituximab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014)) | Last dose of study drug (up to 3 years) | * 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)) |
Countries
Japan
Contacts
STUDY_DIRECTORNobuhito Sanada
Otsuka Pharmaceutical Co., Ltd.
Outcome results
None listed