A Phase III Study of Brentuximab Vedotin plus CHP versus CHOP Therapy for Patients with Previously Untreated CD30-Positive Peripheral T-Cell Lymphoma

Protocol
13-055
Full Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients with CD30-positive Mature T-cell Lymphomas
Phase
III
Purpose

Brentuximab vedotin is approved in the United States for the treatment of systemic anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma. In this study, researchers are evaluating its effectiveness for treating newly diagnosed peripheral T-cell lymphoma (PTCL) when it is given in combination with three standard chemotherapy drugs.

The most common initial treatment for PTCL is CHOP, a combination of the drugs cyclophosphamide, hydroxydaunorubicin, vincristine (Oncovin), and prednisone. Patients in this study will be randomly assigned to receive CHOP, or brentuximab vedotin plus cyclophosphamide, hydroxydaunorubicin, and prednisone (CHP).

Brentuximab 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. Patients in this study must have PTCL that contains the CD30 protein.

Eligibility

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

  • Patients must have previously untreated PTCL that contains the CD30 protein.
  • Patients should 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