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

NCT04049825

Description:

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

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 317-102-00007
  • NCT ID: NCT04049825

Conditions

  • Relapsed or Refractory Diffuse Large B-cell Lymphoma

Interventions

DrugSynonymsArms
OPB-111077Dose Escalation Stage
OPB-111077Dose Expansion Stage

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation StageExperimentalThe 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.
  • OPB-111077
Dose Expansion StageExperimental4 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
  • OPB-111077

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
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicity (DLT)
Time Frame:23days
Safety Issue:
Description:The tolerability of OPB-111077 in combination with bendamustine and rituximab

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description: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))

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Otsuka Pharmaceutical Co., Ltd.

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