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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421667
First Posted: August 23, 2011
Last Update Posted: November 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
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).

Condition Intervention Phase
Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell Drug: brentuximab vedotin Drug: rituximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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).

  • 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.

  • 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

  • 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

  • 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

  • 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

  • Baseline Soluble CD30 Expression [ Time Frame: Baseline ]
    Serum concentration of soluble CD30 before first dose of brentuximab vedotin


Enrollment: 176
Study Start Date: August 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin+rituximab Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion
Experimental: Brentuximab vedotin Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421667


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

Publications:
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01421667     History of Changes
Other Study ID Numbers: SGN35-012
First Submitted: August 19, 2011
First Posted: August 23, 2011
Results First Submitted: June 21, 2016
Results First Posted: October 13, 2016
Last Update Posted: November 28, 2016
Last Verified: June 2015

Keywords provided by Seattle Genetics, Inc.:
Lymphoma, Large B-Cell, Diffuse
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents