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Completed

NCT Number: NCT03259529

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

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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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bendamustine Hydrochloride

Drug

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

Other names: Ribomustin

Gemcitabine 500 mg

Drug

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

Other names: Gemzar

Gemcitabine 700 mg

Drug

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

Other names: Gemzar

Gemcitabine 1000 mg

Drug

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

Other names: Gemzar

Nivolumab

Drug

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

Other names: Opdivo

Rituximab

Drug

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

Primary outcomes

  1. The recommended phase 2 dose (RP2D)

    Time frame: 6 months

    The recommended phase 2 dose (RP2D) of Bendamustine Hydrochloride and Gemcitabine in combination with Nivolumab and Rituximab in patients with Diffuse Large B-cell Lymphoma

  2. Overall Response Rate (ORR)

    Time frame: 12 months

    Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria and duration of response.

Secondary outcomes

  1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

    Time frame: 12 months

    Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

  2. Duration of Response (DOR)

    Time frame: 12 months

  3. Progression-Free Survival (PFS)

    Time frame: 12 months

  4. Overall Survival (OS)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

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

Acronym: BeGeRN

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2017
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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