NCT03259529

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

A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab Combination (BeGeRN) in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine hydrochloride	70 mg/m2 by intravenous (IV) infusion for up to 2 cycles
DRUG	Gemcitabine 500 mg	500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
DRUG	Gemcitabine 700 mg	700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
DRUG	Gemcitabine 1000 mg	1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
DRUG	Nivolumab	1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles
DRUG	Rituximab	375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles

Timeline

• Start date: 2017-03-27
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2017-08-23
• Last updated: 2021-06-07

Locations

1 site across 1 country: Russia