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

This treatment has been approved for sale to the public.
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
History of Changes
  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:

U.S. FDA Resources

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196208

  Show 23 Study Locations
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:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
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 May 16, 2013