This is a multicenter phase III blinded, randomized study, to evaluate the efficacy and safety of two dose levels of DAB389IL-2 in CTCL patients. The objectives of the study are: 1) To demonstrate efficacy of two dose levels of DAB389IL-2 in CTCL patients assessed by the frequency and duration of complete, clinical complete and partial responses, 2) To assess changes in CTCL symptoms and functional status in association with DAB389IL-2 administration, 3) To further evaluate the safety and tolerability of DAB389IL-2 for these doses and schedule, 4) to further characterize the pharmacokinetics of this agent in CTCL patients. An intent-to-treat analysis will be performed, therefore, any patient receiving one dose will be considered evaluable. To date 2 subjects have been enrolled at this site.
Showing the most recent 10 out of 753 publications