Relapsed or Refractory Diffuse Large B-cell Lymphoma Clinical Trial
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)
Verified date | May 2024 |
Source | Otsuka Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
Status | Active, not recruiting |
Enrollment | 36 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Yamagata University Hospital | Yamagata |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity (DLT) | The tolerability of OPB-111077 in combination with bendamustine and rituximab | 23days | |
Primary | Incidence of Adverse events(AEs) | Safety of OPB-111077 in combination with bendamustine and rituximab | Up to 3 years | |
Secondary | 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)) |
Last dose of study drug (up to 3 years) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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