Correlates of capillary leak syndrome (CLS) in patients with cutaneous T-cell lymphoma (CTCL) during treatment with denileukin diftitox (DD) in a placebo (PBO)-controlled phase III trial.

Abstract

e18509 Background: Interleukin-2 therapy is associated with capillary leakage which manifests as hypoalbuminemia, hypotension/intravascular signs of dehydration, with concurrent edema/fluid retention. DD is a recombinant fusion toxin composed of sequences of human IL-2 and diphtheria toxin and is approved for the treatment of CD25+ CTCL. In open-label studies of DD, CLS has been noted. To learn more about the possible association of DD with CLS, we analyzed data from a Phase III trial in CTCL pts with recurrent or persistent stage Ia-III disease. Methods: We examined the clinical reporting of adverse events in any single cycle of therapy for the components of CLS of any severity, identifying 1) hypoalbuminema, 2) dehydration or low blood pressure, and 3) fluid retention or edema. The trial included 144 pts, 44 receiving PBO (mean cycles per pt = 5.1), 45 receiving DD 9 μ g/kg qd × 5 every 21 days (LD) (mean cycles per pt = 5.7), and 55 receiving DD 18 μ g/kg daily × 5 every 21 days (HD) (mean cycles per p...