A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL

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)

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
• 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
• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Relapsed or Refractory Diffuse Large B-cell Lymphoma

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)