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Completed

NCT Number: NCT04049825

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

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

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Key information

Conditions

Relapsed or Refractory Diffuse Large B-cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yamagata University Hospital

Yamagata, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPB-111077

Drug

OPB-111077+bendamustine

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: 23days

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

  2. Incidence of Adverse events(AEs)

    Time frame: Up to 3 years

    Safety of OPB-111077 in combination with bendamustine and rituximab

Secondary outcomes

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

    Time frame: Last dose of study drug (up to 3 years)

    • 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))

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Aug 8, 2019
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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