A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Objective Rate of Response (ORR), defined as CR + CCR + PR
Elyane Lombardy, M.D.
Study Director
Ligand Pharmaceuticals
United States: Food and Drug Administration
93-04-11
NCT00050999
June 1995
December 2006
Name | Location |
---|---|
University of Texas, M.D. Anderson Cancer Center | Houston, Texas 77030 |