Trial | NCT01196208  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Expanded Access

  • Status

    No longer available

  • Study Participants

    None
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
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.
Study Started
Sep 03
2010
Last Update
Sep 21
2020

Drug brentuximab vedotin

Every 21 days by intravenous infusion (1.8 mg/kg)

  • Other names: SGN-35

Criteria 

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
No Results Posted