drugset / Trial / NCT03259529

Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL

NCT03259529

Phase 1/2 Completed 30 enrolled St. Petersburg State Pavlov Medical University
Non-randomizedSequentialOpen-labelTreatment

Summary

Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need for the introduction of novel treatment regimens. This phase I/II trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab.

Timeline

Start
2017-03-27
Primary completion
2020-01-27
Completion
2020-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2 Intravenous
Subject Gemcitabine Small molecule 500 mg/m2 Intravenous
Subject Gemcitabine Small molecule 700 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous