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

Phase 1

Active, not recruiting

• Conditions: Relapsed or Refractory Diffuse Large B-cell Lymphoma
• Interventions: Drug: OPB-111077

• Registration Number: NCT04049825
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-08
• Study Start: 2019-11-22
• Last Update Submitted: 2024-04-30
• Status Verified: 2024-05
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation Stage	OPB-111077	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.
Dose Expansion Stage	OPB-111077	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

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	23days	The tolerability of OPB-111077 in combination with bendamustine and rituximab
Incidence of Adverse events(AEs)	Up to 3 years	Safety of OPB-111077 in combination with bendamustine and rituximab

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yamagata University Hospital; 🇯🇵 Yamagata, Japan