A Phase III Study of Brentuximab Vedotin versus Standard Therapy in Patients with Cutaneous T-Cell Lymphoma

Protocol
13-008
Full Title
A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients with CD30-Positive Cutaneous T-Cell Lymphoma
Phase
III
Purpose

Brentuximab vedotin is a drug approved for treating anaplastic large cell lymphoma and some patients with Hodgkin lymphoma. It has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer. Clinical studies have indicated that it may also be effective for treating some people with cutaneous T-cell lymphoma (CTCL).

The purpose of this study is to compare the effectiveness of brentuximab vedotin with standard therapy (methotrexate or bexarotene) in patients with CD30-positive CTCL that persists despite previous treatment. Patients will be randomly assigned to receive brentuximab vedotin, methotrexate, or bexarotene.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have CTCL that persists despite at least one prior regimen of chemotherapy.
  • Patients’ cancers must be positive for the CD30 protein (the target of brentuximab).
  • At least 3 weeks must have passed since completing prior therapy and entering the study (4 weeks since corticosteroid treatment and 12 weeks since prior immunotherapy).
  • Patients whose CTCL continued to grow despite both methotrexate and bexarotene therapy may not participate.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven M. Horwitz at 212-639-3045.

Disease(s)
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases