A Phase III Study of KW-0761 versus Vorinostat in Patients with Previously Treated Cutaneous T-Cell Lymphoma

Protocol
13-007
Full Title
Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
Phase
III
Purpose

Cutaneous T-cell lymphoma (CTCL) is a form of non-Hodgkin lymphoma that may develop over many years and can become resistant to standard therapy. The purpose of this study is to compare the effectiveness of an investigational drug called KW-0761(mogamulizumab) with an established drug for CTCL called vorinostat in patients with CTCL that has persisted despite standard therapies. KW-0761 is an antibody that targets a protein on CTCL cells called CCR4.

Patients will be randomly assigned to receive KW-0761 or vorinostat. Patients whose CTCL continues to grow while on vorinostat may have the option of receiving KW-0761 instead. KW-0761 is given intravenously (by vein), while vorinostat is taken orally (by mouth).

Eligibility

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

  • Patients must have CTCL that has returned or persisted despite at least one prior regimen of therapy.
  • At least 2 weeks must have passed since prior chemotherapy, immunotherapy, radiation therapy, or other prior treatments and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Moskowitz at 212-639-4839.

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