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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

September 3, 2010
August 30, 2011
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Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01196208 on ClinicalTrials.gov Archive Site
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A Treatment-Option Study of Brentuximab Vedotin in Patients With Progression of Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
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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.

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Expanded Access
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  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
Drug: brentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)
Other Name: SGN-35
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01196208
SGN35-010
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Laurie Grove, PA-C Seattle Genetics, Inc.
Seattle Genetics, Inc.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP