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

September 13, 2018 updated by: Seagen Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • FN BRNO
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Praha, Czechia, 100
        • Fakultni nemocnice Kralovske Vinohrady
  • France
      • Brest, France
        • Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan
      • Caen, France
        • Chu Cote de Nacre - Caen
      • La Roche-sur-Yon, France
        • Centre Hospitalier des Oudairies
      • Le Rocher, France, 72000
        • Centre Hospitalier du Mans
      • Metz, France
        • CHR Metz
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes (CHU Nantes) - Hotel Dieu
      • Perpignan, France
        • Centre Hospitalier de Perpignan
      • Poitiers, France
        • Centre Hospitalier Universitaire (CHU) de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
      • Rennes, France
        • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Brescia, Italy
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Pavia, Italy
        • IRCSS Policlinico San Matteo
      • Roma, Italy, 00161
        • Azienda Policlinico Umberto I di Roma
      • San Giovanni Rotondo, Italy
        • IRCCS Ospedale Casa Sollievo della Sofferenza
      • Varese, Italy
        • A.O Ospadale Di Circolo E Fondazione Macchi
  • Poland
      • Gdańsk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Łódź, Poland, 93-510
        • Wojewodzki Szpital Specjalistyczny
  • Spain
      • Barcelona, Spain
        • Hospital de La Santa Creu i Sant Pau
      • Majadahonda, Spain
        • Hospital Universitario Puerta De Hierro
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa de Zaragoza
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • University Hospital's Birmingham NHS Foundation trust-Queen Elizabeth Hospital
      • Liverpool, United Kingdom
        • Liverpool and Broadgreen Hospital
      • Maidstone, United Kingdom
        • Maidstone and Tunbridge Wells NHS Trust
      • Manchester, United Kingdom
        • Christie Hospital NHS Foundation Trust
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic - West Pueblo
      • Torrance, California, United States, 90501
        • Good Samaritan Hospital
      • Whittier, California, United States, 90603
        • The Oncology Institute of Hope and Innovation
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center
      • Lonetree, Colorado, United States, 80124
        • Kaiser Permanente Oncology
    • Illinois
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Cancer Center
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Saint Francis Cancer Treatment Center
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Hematology and Oncology Associates of Northern New Jersey, P.A.
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Institute and Research Center
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours Saint Francis Hospital
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Institutional Review Board
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Denton, Texas, United States, 76210
        • Texas Oncology - Flower Mound
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Clinical Research
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with confirmed CD30-positive DLBCL or grade 3b follicular non-Hodgkin lymphoma (NHL).

  2. Patients must have relapsed or refractory disease following:

    1. second-line or greater salvage systemic therapy, or
    2. frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
  3. Age 18 years and older.
  4. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET).
  5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  6. Acceptable blood test results.
  7. Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
  8. 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.
  9. Patients must provide written informed consent.

Exclusion Criteria:

  1. 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).
  2. History of progressive multifocal leukoencephalopathy (PML).
  3. Cerebral/meningeal disease related to the underlying malignancy, unless definitively treated.
  4. Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
  5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
  6. Females who are pregnant or breastfeeding.
  7. Known allergy to any study drug or ingredient contained in the drug formulation of any of the study drugs.
  8. 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.
  9. Known to be positive for human immunodeficiency virus (HIV).
  10. Patients with previous allogeneic stem cell transplant.
  11. Previous treatment with brentuximab vedotin or bendamustine.
  12. Intolerable toxicity to prior rituximab therapy.
  13. Current therapy with other investigational agents.
  14. Lung disease unrelated to underlying malignancy.
  15. 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.
  16. Congestive heart failure.
  17. Significant peripheral sensory or motor neuropathy at the start of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brentuximab Vedotin
Subjects 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.
Drug: Rituximab
Other Names:
  • Rituxan
Drug: Bendamustine
Other Names:
  • Treanda
Drug: Brentuximab Vedotin
Other Names:
  • Adcetris
Active Comparator: Rituximab,Bendamustine control
Subjects 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.
Drug: Rituximab
Other Names:
  • Rituxan
Drug: Bendamustine
Other Names:
  • Treanda

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Approximately 1 year
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
Approximately 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Up to 11.8 months
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.
Up to 11.8 months
Complete Remission (CR) Rate
Time Frame: Approximately 1 year
CRR is the proportion of patients who achieve CR (including Complete Metabolic Response (CMR)) as best response to combination therapy on study.
Approximately 1 year
Duration of Response (DOR)
Time Frame: Up to 10.5 months
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.
Up to 10.5 months
Overall Survival (OS)
Time Frame: Up to 1.5 years
OS is defined as the time randomization to death from any cause
Up to 1.5 years
Number and Severity of Adverse Events (AEs)
Time Frame: Approximately 1 year
All AEs are included in the summaries, unless treatment-emergent is specified.
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Thomas Manley, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGN35-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings