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

Description

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.

Study Start Date

Not specified

Estimated Completion Date

August 2017

Interventions

  • Drug: brentuximab vedotin

Specialties

  • Internal Medicine: Hematology/Oncology
  • Nursing: Hematology/Oncology
  • Oncology: Leukemia/Lymphoma
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Hodgkin Disease
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic

Study ID

Seattle Genetics, Inc. -- SGN35-010

Status

Available

Trial ID

NCT01196208

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Seattle Genetics, Inc.

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
Stanford Cancer Center - Stanford, California 2,694.5 miles None None None

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