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Diffuse Large B-cell Lymphoma RefractoryPhase 2NCT02594163

Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma

A Phase 2 study testing Brentuximab Vedotin, Rituximab and Bendamustine in people with Diffuse Large B-cell Lymphoma Refractory and Follicular B-cell Non-Hodgkin's Lymphoma, run by Seagen Inc. at 50 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Brentuximab Vedotin, Rituximab and Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
50 sitesin 7 countries
Study dates
Oct 2015to Sep 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with confirmed CD30-positive DLBCL or grade 3b follicular non-Hodgkin lymphoma (NHL).
  • Patients must have relapsed or refractory disease following:
  • second-line or greater salvage systemic therapy, or
  • frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
  • Age 18 years and older.
  • Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET).
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  • An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  • Acceptable blood test results.
  • Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
  • Females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin or 12 months following the last dose of rituximab, whichever is later.
  • Patients must provide written informed consent.

Who cannot join

  • History of another invasive malignancy that has not been in remission for at least 1 year. (Exceptions are nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma, and cervical carcinoma or a squamous intraepithelial lesion on PAP smear).
  • History of progressive multifocal leukoencephalopathy (PML).
  • Cerebral/meningeal disease related to the underlying malignancy, unless definitively treated.
  • Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
  • Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
  • Females who are pregnant or breastfeeding.
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  • Known allergy to any study drug or ingredient contained in the drug formulation of any of the study drugs.
  • Known to be positive for hepatitis B. Known to have active hepatitis C infection or on antiviral therapy for hepatitis C within the last 6 months.
  • Known to be positive for human immunodeficiency virus (HIV).
  • Patients with previous allogeneic stem cell transplant.
  • Previous treatment with brentuximab vedotin or bendamustine.
  • Intolerable toxicity to prior rituximab therapy.
  • Current therapy with other investigational agents.
  • Lung disease unrelated to underlying malignancy.
  • History of a stroke or transient ischemic attack, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to the first dose of treatment.
  • Congestive heart failure.
  • Significant peripheral sensory or motor neuropathy at the start of the study.

Trial locations and contacts

50 sites in 7 countries.

50 sites in 7 countries

United States22 sites

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Texas Oncology - Flower Mound

    Denton, Texas, 76210

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • Bon Secours Saint Francis Hospital

    Greenville, South Carolina, 29607

  • Greenville Health System Institutional Review Board

    Greenville, South Carolina, 29615

  • Kaiser Permanente Oncology

    Lonetree, Colorado, 80124

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Hematology and Oncology Associates of Northern New Jersey, P.A.

    Morristown, New Jersey, 07962

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • Sansum Clinic - West Pueblo

    Santa Barbara, California, 93105

  • Virginia Mason Clinical Research

    Seattle, Washington, 98101

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Good Samaritan Hospital

    Torrance, California, 90501

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

Other trials in United States

France9 sites

  • Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan

    Brest

  • CHU Côte de Nacre - Caen

    Caen

  • Centre Hospitalier des Oudairies

    La Roche-sur-Yon

  • Centre Hospitalier du Mans

    Le Rocher, 72000

  • CHR Metz

    Metz

  • Centre Hospitalier Universitaire de Nantes (CHU Nantes) - Hotel Dieu

    Nantes

  • Centre Hospitalier de Perpignan

    Perpignan

  • Centre Hospitalier Universitaire (CHU) de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

    Poitiers

  • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

    Rennes

Other trials in France

Italy6 sites

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia

  • IRCSS Policlinico San Matteo

    Pavia

  • Azienda Policlinico Umberto I di Roma

    Roma, 00161

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • A.O Ospadale Di Circolo E Fondazione Macchi

    Varese

Other trials in Italy

Spain4 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitario Puerta de Hierro

    Majadahonda

  • Hospital Universitario La Fe

    Valencia

  • Hospital Clinico Universitario Lozano Blesa de Zaragoza

    Zaragoza

Other trials in Spain

United Kingdom4 sites

  • University Hospital's Birmingham NHS Foundation trust-Queen Elizabeth Hospital

    Birmingham, B15 2GW

  • Liverpool and Broadgreen Hospital

    Liverpool

  • Maidstone and Tunbridge Wells NHS Trust

    Maidstone

  • Christie Hospital NHS Foundation Trust

    Manchester

Other trials in United Kingdom

Czechia3 sites

  • FN Brno

    Brno, 625 00

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultní nemocnice Královské Vinohrady

    Prague, 100

Other trials in Czechia

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Wojewódzki Szpital Specjalistyczny

    Lodz, 93-510

Other trials in Poland

About this study

Official title: A Randomized, Open Label, Phase 2 Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for Relapsed or Refractory CD30-Positive Diffuse Large B-Cell Lymphoma

This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).

Read the detailed description

Patients will be randomized in a 1:1 manner to receive rituximab plus bendamustine with or without brentuximab vedotin. Patients who respond to combination treatment containing brentuximab vedotin and do not experience excessive toxicity may receive additional single-agent brentuximab vedotin following combination treatment, for up to an additional 10 cycles (up to 16 total cycles of treatment).

Being tested
Brentuximab Vedotin, Rituximab, Bendamustine

What participants receive

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

  • Brentuximab VedotinDrug

    Also called Adcetris

  • RituximabDrug

    Also called Rituxan

  • BendamustineDrug

    Also called Treanda

Study groups in NCT02594163
Study groupRoleWhat they receive
Brentuximab VedotinExperimentalSubjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.
Receives: Drug: Brentuximab Vedotin; Drug: Rituximab; Drug: Bendamustine
Rituximab,Bendamustine controlActive comparatorSubjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.
Receives: Drug: Rituximab; Drug: Bendamustine

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieve a Complete Response (CR) (including Complete Metabolic Response (CMR)) or Partial Response (PR) (including Partial Metabolic Response (PMR)) as best response to combination therapy on study

    Measured: Approximately 1 year

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to disease progression/relapse, receipt of subsequent lymphoma chemotherapy other than the components of the study treatment regimen, or death from any cause, whichever occurs first.

    Measured: Up to 11.8 months

  2. Complete Remission (CR) Rate

    CRR is the proportion of patients who achieve CR (including Complete Metabolic Response (CMR)) as best response to combination therapy on study.

    Measured: Approximately 1 year

  3. Duration of Response (DOR)

    DOR is defined as the time from first observation of response to disease progression/relapse, receipt of subsequent lymphoma chemotherapy other than the components of the study treatment regimen, or death from any cause, whichever occurs first.

    Measured: Up to 10.5 months

  4. Overall Survival (OS)

    OS is defined as the time randomization to death from any cause

    Measured: Up to 1.5 years

  5. Number and Severity of Adverse Events (AEs)

    All AEs are included in the summaries, unless treatment-emergent is specified.

    Measured: Approximately 1 year

Timeline

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

  1. First posted2 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Why it stopped: Sponsor decision based on portfolio prioritization

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02594163
Sponsor's protocol ID
SGN35-023
Status last verified
Sep 2018
First submitted
30 Oct 2015
Last updated
16 Oct 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab Vedotin, Rituximab and Bendamustine in people with Diffuse Large B-cell Lymphoma Refractory and Follicular B-cell Non-Hodgkin's Lymphoma, run by Seagen Inc. at 50 sites in 7 countries.

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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, France, Italy, Spain, United Kingdom and 2 more countries. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: Approximately 1 year). 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 NCT02594163.

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 16 Oct 2018.

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