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
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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...
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Houston, Texas 77030
Principal Investigator: David Fisher
Phone: 267-464-2575
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