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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04049825
Other study ID # 317-102-00007
Secondary ID jRCT2080224718
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 22, 2019
Est. completion date March 2025

Study information

Verified date May 2024
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OPB-111077
OPB-111077+bendamustine
OPB-111077
OPB-111077+rituximab+bendamustine

Locations

Country Name City State
Japan Yamagata University Hospital Yamagata

Sponsors (1)

Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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)
See also
  Status Clinical Trial Phase
Withdrawn NCT04279938 - A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL Phase 1
Suspended NCT04607772 - Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) Phase 1/Phase 2
Active, not recruiting NCT06074107 - Study of BEBT-908 in the Relapsed or Refractory Diffuse Large B-cell Lymphoma Subjects Phase 2
Active, not recruiting NCT05144841 - A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004) Phase 2