A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Status: | Available |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 6 - Any |
Updated: | 9/19/2018 |
Contact: | Dmitry Yastrebov |
Email: | dmitry.yastrebov@psi-cro.com |
Phone: | 41412281000 |
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
The purpose of this study is to provide the option of brentuximab vedotin treatment to
eligible patients in studies SGN35-005 and C25001
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.
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.
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
We found this trial at
4
sites
Houston, Texas 77030
Principal Investigator: David Fisher
Phone: 267-464-2575
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Phone: 267-464-2575
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials