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

Use our guide to learn which trials are right for you!

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

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.

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
Stanford, California 94305
Phone: 267-464-2575
?
mi
from
Stanford, CA
Click here to add this to my saved trials
450 Brookline Ave
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: David Fisher
Phone: 267-464-2575
?
mi
from
Houston, TX
Click here to add this to my saved trials
Melbourne,
Principal Investigator: Miles Prince
?
mi
from
Melbourne,
Click here to add this to my saved trials