An SGN-35 Trial for Patients Who Have Previously Participated in an SGN-35 Study

This study has been completed.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc. Identifier:
First received: July 24, 2009
Last updated: May 1, 2013
Last verified: May 2013

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with SGN-35 in patients who have previously participated in an SGN-35 study.

Condition Intervention Phase
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Drug: SGN-35
Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response, progression-free survival, and overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Up to 1 month post last dose ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: SGN-35
Every 21 days by intravenous infusion (1.2 or 1.8 mg/kg)
Other Name: brentuximab vedotin


Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participated in a previous SGN-35 study.
  • CD30-positive hematologic malignancy.
  • At a minimum, experienced clinical benefit in the prior SGN-35 study. For retreatment, patients must have previously achieved either complete or partial remission with SGN-35 and experienced disease progression after discontinuing the prior SGN-35 study.

Exclusion Criteria:

Withdrew consent to participate in any prior SGN-35 study.

  Contacts and Locations
Please refer to this study by its identifier: NCT00947856

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Loyola University Medical Center - Cardinal Bernadin Cancer Center
Maywood, Illinois, United States, 60153
United States, Indiana
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
The John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
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
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Texas
Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
MD Anderson Cancer Center /The University of Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States, 98109-1023
Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, France, 75475
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Laurie Grove, PA-C Seattle Genetics, Inc.
  More Information

No publications provided by Seattle Genetics, Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc. Identifier: NCT00947856     History of Changes
Other Study ID Numbers: SGN35-006
Study First Received: July 24, 2009
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Monomethylauristatin E

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell processed this record on April 17, 2014