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

NCT03259529 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Principal Investigators

  • Boris V Afanasyev, Ph.D · St. Petersburg State Pavlov Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259529 on ClinicalTrials.gov