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Diffuse Large B Cell LymphomaPhase 1/2BeGeRNNCT03259529

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

A Phase 1/2 study testing Bendamustine hydrochloride, Gemcitabine 500 mg and Gemcitabine 700 mg in people with Diffuse Large B Cell Lymphoma, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Bendamustine hydrochloride, Gemcitabine 500 mg and Gemcitabine 700 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteRussia
Study dates
27 Mar 2017to 27 Jan 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • First Pavlov State Medical University of St. Petersburg

    Saint Petersburg, 197089

Other trials in Russia

About this study

Official 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

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.

Being tested
Bendamustine hydrochloride, Gemcitabine 500 mg, Gemcitabine 700 mg, Gemcitabine 1000 mg, Nivolumab
Keywords
Diffuse Large B-cell Lymphoma, Nivolumab, Bendamustine Hydrochloride, Gemcitabine, Rituximab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bendamustine hydrochlorideDrug

    Also called Ribomustin

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

  • Gemcitabine 500 mgDrug

    Also called Gemzar

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

  • Gemcitabine 700 mgDrug

    Also called Gemzar

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

  • Gemcitabine 1000 mgDrug

    Also called Gemzar

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

  • NivolumabDrug

    Also called Opdivo

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

  • RituximabDrug

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

Study groups in NCT03259529
Study groupRoleWhat they receive
Gemcitabine 500ExperimentalDays 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
Receives: Drug: Bendamustine hydrochloride; Drug: Gemcitabine 500 mg; Drug: Nivolumab; Drug: Rituximab
Gemcitabine 700ExperimentalDays 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
Receives: Drug: Bendamustine hydrochloride; Drug: Gemcitabine 700 mg; Drug: Nivolumab; Drug: Rituximab
Gemcitabine 1000ExperimentalDays 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
Receives: Drug: Bendamustine hydrochloride; Drug: Gemcitabine 1000 mg; Drug: Nivolumab; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The recommended phase 2 dose (RP2D)

    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

    Measured: 6 months

  2. Overall Response Rate (ORR)

    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.

    Measured: 12 months

Secondary outcomes (4)

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

    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).

    Measured: 12 months

  2. Duration of Response (DOR)

    Measured: 12 months

  3. Progression-Free Survival (PFS)

    Measured: 12 months

  4. Overall Survival (OS)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start27 Mar 2017
  3. Primary completion27 Jan 2020
  4. Study completion27 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259529
Sponsor's protocol ID
DLBCL BeGeRN 1/2
Acronym
BeGeRN
Status last verified
Jun 2021
First submitted
22 Aug 2017
Last updated
7 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bendamustine hydrochloride, Gemcitabine 500 mg and Gemcitabine 700 mg in people with Diffuse Large B Cell Lymphoma, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The recommended phase 2 dose (RP2D) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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