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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2020-01-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

There will be 2 parts in this study. In Part 1, the safety of combination treatment will be evaluated prior to expansion of enrollment to evaluate treatment effect in Part 2. The arms in Part 1 include 3 different dosage regimens of gemcitabine (500 / 700 / 1000). Part 2 of the study will further characterize the safety and evaluate the antitumor activity of drug combination by enrolling patients at the recommended dose schedule determined in Part 1.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Bendamustine hydrochloride

Intervention Type DRUG

70 mg/m2 by intravenous (IV) infusion for up to 2 cycles

Gemcitabine 500 mg

Intervention Type DRUG

500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles

Nivolumab

Intervention Type DRUG

1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles

Rituximab

Intervention Type DRUG

375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles

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

Group Type EXPERIMENTAL

Bendamustine hydrochloride

Intervention Type DRUG

70 mg/m2 by intravenous (IV) infusion for up to 2 cycles

Gemcitabine 700 mg

Intervention Type DRUG

700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles

Nivolumab

Intervention Type DRUG

1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles

Rituximab

Intervention Type DRUG

375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles

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

Group Type EXPERIMENTAL

Bendamustine hydrochloride

Intervention Type DRUG

70 mg/m2 by intravenous (IV) infusion for up to 2 cycles

Gemcitabine 1000 mg

Intervention Type DRUG

1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles

Nivolumab

Intervention Type DRUG

1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles

Rituximab

Intervention Type DRUG

375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles

Interventions

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Bendamustine hydrochloride

70 mg/m2 by intravenous (IV) infusion for up to 2 cycles

Intervention Type DRUG

Gemcitabine 500 mg

500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles

Intervention Type DRUG

Gemcitabine 700 mg

700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles

Intervention Type DRUG

Gemcitabine 1000 mg

1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles

Intervention Type DRUG

Nivolumab

1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles

Intervention Type DRUG

Rituximab

375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles

Intervention Type DRUG

Other Intervention Names

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Ribomustin Gemzar Gemzar Gemzar Opdivo

Eligibility Criteria

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Inclusion Criteria

* Diagnosis: Histologically confirmed diffuse large B-cell lymphoma
* Refractory or relapsed after at least two prior lines of treatment (i.e. induction and salvage regimen) for diffuse large B-cell lymphoma.
* Age 18-70 years old
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No