Relapsed or refractory diffuse large B-cell lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : OPB-111077
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mater
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "1) Patients age 20 to 80 years, inclusive (at time of informed consent) 2) Patients with a definite diagnosis of DLBCL 3) Patients who have received at least initial standard treatment 4) Patients with measurable lesions (based on International Working Group [IWG] 2014 criteria) 5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 Only for dose-expansion stage 6) Patients who are pathologically diagnosed as CD20 positive lymphoma 7) Patients who have a history of being treated with 1 to 5 regimens of previous chemotherapy for the underlying disease"
Exclusion criteria
Exclusion criteria: 1.Patients who are candidates for autologous or allogeneic hematopoietic stem cell transplantation 2.Patients who were refractory to initial standard treatment 3.Patients who have a history of bendamustine administration and are intolerant to bendamustine 4.Patients with central nervous system (CNS) involvement of lymphoma or with a history of CNS involvement of lymphoma 5.Patients diagnosed with DLBCL transformed from low-grade B-cell non-Hodgkin's lymphoma (NHL) Only for dose-expansion stage 6.Patients who have a history of rituximab administration and are intolerant to rituximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Dose Limiting Toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacogenomics Efficacy, Pharmacokinetics, Biomarker | — |
Countries
Asia except Japan, Japan
Outcome results
None listed