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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01421667
First received: August 19, 2011
Last updated: November 13, 2014
Last verified: November 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Incidence of adverse events with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Correlation between CD30 expression and antitumor activity with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) biomarkers [ Time Frame: Pre-dose at each cycle ] [ Designated as safety issue: No ]
  • Objective response rate with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: August 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Chicago
Chicago, Illinois, United States, 60637-1470
Northwestern University
Chicago, Illinois, United States, 60611
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
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10019
NYU Clinical Cancer Center
New York, New York, United States, 10016
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
Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75230
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

No publications provided by Seattle Genetics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01421667     History of Changes
Other Study ID Numbers: SGN35-012
Study First Received: August 19, 2011
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration

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, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014