A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
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
Estimated Completion Date
- Drug: brentuximab vedotin
- Internal Medicine: Hematology/Oncology
- Nursing: Hematology/Oncology
- Oncology: Leukemia/Lymphoma
- Physician Assistant: Hematology/Oncology
- Hodgkin Disease
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Large-Cell, Anaplastic
Seattle Genetics, Inc. -- SGN35-010
Seattle Genetics, Inc.
- 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.
- 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
6 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (2)
|DanaFarber Cancer Institute - Boston, Massachusetts||2.6 miles||None||None||None|
|Stanford Cancer Center - Stanford, California||2,694.5 miles||None||None||None|