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

Primary Purpose

Relapsed or Refractory Diffuse Large B-cell Lymphoma

Status

Recruiting

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

OPB-111077

About this trial

This is an interventional treatment trial for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Patients who are pathologically diagnosed as CD20 positive lymphoma
Patients who have a history of being treated with 1 to 3 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)

- Patients who have a history of rituximab administration and are intolerant to rituximab

Sites / Locations

Yamagata University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dose Escalation Stage

Dose Expansion Stage

Arm Description

The dose of OPB-111077 in the first cohort will be 200 mg/day, increasing as appropriate to 400 mg/day in the second cohort and then to 600 mg/day in the third cohort.

4 days on and 3days off of 21-day cycles of OPB-111077 Day 1 of 21-days cycles of rituximab Day 2 and 3 of 21-day cycles of bendamustine

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)

The tolerability of OPB-111077 in combination with bendamustine and rituximab

Incidence of Adverse events(AEs)

Safety of OPB-111077 in combination with bendamustine and rituximab

Secondary Outcome Measures

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))

Full Information

NCT ID

NCT04049825

First Posted

July 9, 2019

Last Updated

November 13, 2022

Sponsor

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04049825

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 22, 2019 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed or Refractory Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation Stage

Arm Type

Experimental

Arm Description

The dose of OPB-111077 in the first cohort will be 200 mg/day, increasing as appropriate to 400 mg/day in the second cohort and then to 600 mg/day in the third cohort.

Arm Title

Dose Expansion Stage

Arm Type

Experimental

Arm Description

4 days on and 3days off of 21-day cycles of OPB-111077 Day 1 of 21-days cycles of rituximab Day 2 and 3 of 21-day cycles of bendamustine

Intervention Type

Drug

Intervention Name(s)

OPB-111077

Intervention Description

OPB-111077+bendamustine

Intervention Type

Drug

Intervention Name(s)

OPB-111077

Intervention Description

OPB-111077+rituximab+bendamustine

Primary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT)

Description

The tolerability of OPB-111077 in combination with bendamustine and rituximab

Time Frame

23days

Title

Incidence of Adverse events(AEs)

Description

Safety of OPB-111077 in combination with bendamustine and rituximab

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

Efficacy based on International working group(IWG) Lugano response criteria for Non Hodgkin's lymphoma ( (NHL) (2014))

Description

Time Frame

Last dose of study drug (up to 3 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 3 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Drug Information Center

Phone

+81-3-6361-7314

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nobuhito Sanada

Organizational Affiliation

Otsuka Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Yamagata University Hospital

City

Yamagata

Country

Japan

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The focus of this study is a rare disease.

Learn more about this trial

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

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