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

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT03259529
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 27, 2017
Status verified
Jun 2021
Primary completion
Jan 27, 2020
Completion
Jan 27, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine 500
    Days 1,2 Bendamustine Hydrochloride 70 mg/m2/day iv; Days 1,8,15 Gemcitabine 500 mg/m2/day iv; Days 1,15 Nivolumab 1mg/kg/day iv; Day 0 Rituximab 375mg/kg/day iv. Duration of cycle 28 days
  • Experimental: Gemcitabine 700
    Days 1,2 Bendamustine Hydrochloride 70 mg/m2/day iv; Days 1,8,15 Gemcitabine 700 mg/m2/day iv; Days 1,15 Nivolumab 1mg/kg/day iv; Day 0 Rituximab 375mg/kg/day iv. Duration of cycle 28 days
  • Experimental: Gemcitabine 1000
    Days 1,2 Bendamustine Hydrochloride 70 mg/m2/day iv; Days 1,8,15 Gemcitabine 1000 mg/m2/day iv; Days 1,15 Nivolumab 1mg/kg/day iv; Day 0 Rituximab 375mg/kg/day iv. Duration of cycle 28 days

Primary Outcome Measure

The recommended phase 2 dose (RP2D) [ Time Frame: 6 months ]

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