Phase I study of alemtuzumab for therapy of steroid-refractory chronic graft-versus-host disease.

ABSTRACT: Steroid-refractory chronic graft-versus-host disease (cGVHD) carries a poor prognosis with no agreed upon algorithm for treatment. Because both B and T cells contribute to the pathophysiology of cGVHD, we conducted a phase I study in subjects with steroid-refractory cGVHD using the anti-CD52 antibody alemtuzumab to transiently deplete most mononuclear subsets. Three regimens were investigated in a 3+3 dose-escalation design: 3 mg × 6 (dose level 1), 3 mg × 1, then 10 mg × 5 (dose level 2) and 3 mg × 1, 10 mg × 1, then 30 mg × 4 (dose level 3) administered over 4 weeks. The maximum tolerated dose of alemtuzumab was dose level 2. Thirteen patients were assessable for toxicities, which were primarily infectious and hematologic. Rates of infectious complications in the first 12 weeks were 0% a

SUBMITTER: Nikiforow S 

PROVIDER: S-EPMC3642980 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature