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A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

Expanded access is currently available for this treatment.
Verified January 2016 by Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc. Identifier:
First received: September 3, 2010
Last updated: April 12, 2016
Last verified: January 2016
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

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

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

Resource links provided by NLM:

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

Estimated Study Completion Date: August 2017
Intervention Details:
    Drug: brentuximab vedotin
    Every 21 days by intravenous infusion (1.8 mg/kg)
    Other Name: SGN-35
Detailed Description:
The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
  • Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

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 breastfeeding
  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 identifier: NCT01196208

Contact: Dmitry Yastrebov 41412281000

  Show 31 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Liga Ulmane, MD PSI Company Ltd.
  More Information

Responsible Party: Seattle Genetics, Inc. Identifier: NCT01196208     History of Changes
Other Study ID Numbers: SGN35-010  2010-020363-21 
Study First Received: September 3, 2010
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Cutaneous
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016