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

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: OPB-111077; Drug: OPB-111077

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Drug Information Center; Phone Number: +81-3-6361-7314

Study Locations

• Japan
  • Yamagata, Japan
    • Yamagata University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Stage; 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.	Drug: OPB-111077; OPB-111077+bendamustine; Drug: OPB-111077; OPB-111077+rituximab+bendamustine
Experimental: Dose Expansion Stage; 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	Drug: OPB-111077; OPB-111077+bendamustine; Drug: OPB-111077; OPB-111077+rituximab+bendamustine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	The tolerability of OPB-111077 in combination with bendamustine and rituximab	23days
Incidence of Adverse events(AEs)	Safety of OPB-111077 in combination with bendamustine and rituximab	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Nobuhito Sanada, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: 317-102-00007; jRCT2080224718 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The focus of this study is a rare disease.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No