A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

October 14, 2016 updated by: Seagen Inc.

A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • 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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope
      • Oxnard, California, United States, 93030
        • PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
      • Stanford, California, United States, 94305-5821
        • Stanford Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers - Aurora
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • St. Augustine, Florida, United States, 32086
        • Cancer Specialists of North Florida - St. Augustine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology P.A.
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C.
      • New York, New York, United States, 10016
        • NYU Clinical Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10019
        • Columbia University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, The
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer and Research / USOR
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • St. Francis Hospital
    • Texas
      • Dallas, Texas, United States, 75230
        • Texas Oncology - Medical City Dallas
      • Dallas, Texas, United States, 75246
        • Charles A. Sammons Cancer Center
      • Fort Worth, Texas, United States, 76132
        • Texas Oncology-Southwest Fort Worth
      • Houston, Texas, United States, 77030-4003
        • MD Anderson Cancer Center / University of Texas
      • Round Rock, Texas, United States, 78665
        • Texas Oncology - Seton Williamson
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute Medical Oncology
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance / University of Washington Medical Center
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C.

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

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically-confirmed NHL (DLBCL only for Parts B and C)
  • Relapsed or refractory disease following at least 1 prior systemic therapy
  • Measurable disease of at least 1.5 cm as documented by CT
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

  • History of another primary invasive malignancy that has not been in remission for at least 3 years
  • Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
  • B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
  • Known cerebral/meningeal disease

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brentuximab vedotin
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Experimental: Brentuximab vedotin+rituximab
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
Time Frame: Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
Time Frame: Up to 3 years
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab
Time Frame: Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Complete Remission (CR) Rate by Investigator
Time Frame: Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
Time Frame: Up to approximately 3 years
Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
Time Frame: Up to approximately 3 years
Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
Time Frame: Up to approximately 3 years
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Up to approximately 3 years
Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
Time Frame: Up to 3 years
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).
Up to 3 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
Time Frame: Up to 3 years
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Up to 3 years
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)
Time Frame: 1 day
End of infusion concentration of ADC following the first dose of brentuximab vedotin
1 day
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)
Time Frame: 3 weeks
Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)
Time Frame: 3 weeks
Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Time Frame: 3 weeks
Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Baseline Soluble CD30 Expression
Time Frame: Baseline
Serum concentration of soluble CD30 before first dose of brentuximab vedotin
Baseline

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-012

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.

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