Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous
Conditions
Keywords
Disease, Hodgkin, Lymphoma, Monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Hematologic Diseases, Immunotherapy
Brief summary
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
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.
Interventions
DRUGbrentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)
Sponsors
Millennium Pharmaceuticals, Inc.
Seagen Inc.
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
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
Countries
Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed