A Treatment-Option Study of Brentuximab Vedotin in Patients With Progression of Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma

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Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01196208
First received: September 3, 2010
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to provide the option of brentuximab vedotin treatment to patients randomly allocated to placebo treatment in the Phase 3 study SGN35-005 that experienced disease progression of HL. Additionally in the US only, the purpose of this study is to provide access to brentuximab vedotin for patients with relapsed or refractory HL or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.


Condition Intervention
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Drug: brentuximab vedotin

Study Type: Expanded Access     What is Expanded Access?

Resource links provided by NLM:


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

Intervention Details:
    Drug: brentuximab vedotin
    Every 21 days by intravenous infusion (1.8 mg/kg)
    Other Name: SGN-35
  Eligibility

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

Inclusion Criteria:

  • Participated in the placebo arm of the SGN35-005 clinical study and experienced disease progression of HL as defined by the SGN35-005 study protocol. Or in the US only: Patients with relapsed or refractory HL or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.
  • Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin, unless underlying disease is progressing on therapy.

Exclusion Criteria:

  • History of another primary malignancy that has not been in remission for at least 3 years
  • Known cerebral/meningeal disease
  • Peripheral neuropathy of grade 2 or greater
  • Females who are pregnant or lactating
  • Patients who are eligible to participate in other brentuximab vedotin clinical studies
  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: NCT01196208

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
Duarte, California, United States, 91010
Stanford, California, United States, 94305
United States, Colorado
Denver, Colorado, United States, 80218
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Maywood, Illinois, United States, 60153
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New York, New York, United States, 10021
New York, New York, United States, 10016
Rochester, New York, United States, 14642
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Laurie Grove, PA-C Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01196208     History of Changes
Other Study ID Numbers: SGN35-010
Study First Received: September 3, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Disease, Hodgkin
Lymphoma
Monomethylauristatin E
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Hematologic Diseases
Immunotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014