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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049825
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Diffuse Large B-cell Lymphoma Drug: OPB-111077 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023


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

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+rituximab+bendamustine




Primary Outcome Measures :
  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 Outcome Measures :
  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))



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049825


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
Yamagata University Hospital Recruiting
Yamagata, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04049825    
Other Study ID Numbers: 317-102-00007
JapicCTI-194794 ( Other Identifier: JapicCTI )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The focus of this study is a rare disease.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin