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)

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Brief summary

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

Study ID 317-102-00007 jRCT2080224718 NCT04049825
Fase Phase 1
Enrollment 36
Study type Interventional
Has expanded access -

Locations

Japan
  • Yamagata University Hospital, Yamagata, Japan
    Recruiting

Design info

Non-Randomized Parallel Assignment Treatment None (Open Label)

Drug

  • Drug: OPB-111077

    OPB-111077+bendamustine

  • Drug: OPB-111077

    OPB-111077+rituximab+bendamustine

Condition

  • Relapsed or Refractory Diffuse Large B-cell Lymphoma

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 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
  • Gender: all
  • Age: 20 - 80
  • Healthy volunteers: no
  • Therapy type: -
  • Therapy Specification: -

Contact information

Local contact information

Overall contact

  • Lastname overall: Nobuhito Sanada
  • Role: Study Director
  • Affiliation: Otsuka Pharmaceutical Co., Ltd.
  • NordicNect: No
Verification date 2024-05-01
Study first submitted 2019-07-09
Study first posted 2019-08-08
Last update submitted 2024-04-30
Last update posted 2024-05-02

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