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A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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)

NCT04049825•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Yamagata University Hospital

Yamagata, Japan

Key Dates

Start Date

November 22, 2019

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

May 2, 2024

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory Diffuse Large B-cell Lymphoma

Interventions

OPB-111077

DRUG

OPB-111077

DRUG

Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)

NCT04607772

Relapsed or Refractory Diffuse Large B-Cell Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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