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
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients achieving an objective response that lasts at least 4 months
To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm
Change in response at the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment
No
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C25001
NCT01578499
May 2012
May 2017
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Stanford Cancer Center | Stanford, California 94305-5824 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Boston University Medical Center | Boston, Massachusetts 02118 |
John Theurer Cancer Center (Hackensack University Medical Center) | Hackensack, New Jersey 07601 |
UCLA Hematology Oncology | Santa Monica, California 90404 |