Data monitoring of a placebo-controlled trial of daclizumab in acute graft-versus-host disease

David Zahrieh, Stephanie J. Lee, David Harrington

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

This trial was undertaken to test the hypothesis that two-drug initial therapy for acute graft-versus-host disease (GVHD) would produce better control of GVHD and less exposure to corticosteroids than the standard treatment of corticosteroids alone. All participants had undergone allogeneic hematopoietic stem cell transplantation (HSCT) and developed acute GVHD. Subjects were randomized to treatment with corticosteroids plus placebo or corticosteroids plus daclizumab. The trial was continued past its first interim analysis (~30%; evaluable subjects) but was stopped after the second interim analysis (~50%; evaluable subjects) when the two-drug arm was associated with worse overall survival.

Original languageEnglish (US)
Title of host publicationData Monitoring in Clinical Trials
Subtitle of host publicationA Case Studies Approach
PublisherSpringer US
Pages269-277
Number of pages9
ISBN (Print)0387203303, 9780387203300
DOIs
StatePublished - Dec 1 2006

ASJC Scopus subject areas

  • Mathematics(all)

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    Zahrieh, D., Lee, S. J., & Harrington, D. (2006). Data monitoring of a placebo-controlled trial of daclizumab in acute graft-versus-host disease. In Data Monitoring in Clinical Trials: A Case Studies Approach (pp. 269-277). Springer US. https://doi.org/10.1007/0-387-30107-0_25