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

Otsuka

Status and phase: Active, not recruiting; Phase 1

Conditions: Relapsed or Refractory Diffuse Large B-cell Lymphoma

Treatments: Drug: OPB-111077

Study type: Interventional

Funder types: Industry

Identifiers

NCT04049825

jRCT2080224718 (Other Identifier)

317-102-00007

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Dose Escalation Stage

Experimental group

Description:

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.

Treatment:

Drug: OPB-111077

Drug: OPB-111077

Dose Expansion Stage

Experimental group

Description:

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

Treatment:

Drug: OPB-111077

Drug: OPB-111077