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

NCT04049825 | Completed Phase 1

• 2 other identifiers: 317-102-00007jRCT2080224718
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Efficacy 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)

Study Arms (2)

Dose Escalation Stage

EXPERIMENTAL

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

Dose Expansion Stage

EXPERIMENTAL

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

Interventions

OPB-111077 DRUG

OPB-111077+bendamustine

Dose Escalation Stage

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Yamagata University Hospital

Yamagata, Japan

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: August 8, 2019
• Study Start: November 22, 2019
• Primary Completion: March 25, 2025
• Study Completion: January 19, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)