Multicenter phase II trial of enzastaurin in patients with relapsed or refractory advanced cutaneous T-cell lymphoma

Christiane Querfeld, Timothy M. Kuzel, Youn H. Kim, Pierluigi Porcu, Madeleine Duvic, Amy Musiek, Alain H. Rook, Lawrence A. Mark, Lauren Pinter-Brown, Oday Hamid, Boris Lin, Ying Bian, Mark Boye, Jeannette M. Day, Steven T. Rosen

Research output: Contribution to journalArticle

25 Scopus citations

Abstract

This multicenter, single-arm, open-label non-randomized phase II trial (NCT00744991) was conducted in patients with recurrent/refractory mycosis fungoides (MF), stage IBIVB, or Sézary syndrome (SS). A Simon two-stage design required 25 patients enrolled in stage 1 with ≥7 confirmed objective responses for expansion into stage 2. Patients were treated with oral enzastaurin (250 mg twice daily) until disease progression or intolerable toxicity. The primary endpoint was investigator-assessed response rate; secondary endpoints were time to objective response, response duration, time-to-progression, patient-reported pruritus, and safety/tolerability. Twenty-five patients were enrolled. A partial response was observed in one patient with MF. Median time-to-progression was 78 and 44 days in MF and SS, respectively. Self-reported pruritus relief and improved composite pruritus-specific symptom scores were documented in six and four patients, respectively. Enzastaurin was well tolerated with mostly grade 12 adverse events, mainly diarrhea and fatigue. There were two adverse event-related drug discontinuations with one possibly treatment-related.

Original languageEnglish
Pages (from-to)1474-1480
Number of pages7
JournalLeukemia and Lymphoma
Volume52
Issue number8
DOIs
StatePublished - Aug 1 2011
Externally publishedYes

Keywords

  • Enzastaurin
  • patient-reported outcome
  • phase II trial
  • pruritus
  • relapsed/refractory cutaneous T-cell lymphoma

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    Querfeld, C., Kuzel, T. M., Kim, Y. H., Porcu, P., Duvic, M., Musiek, A., Rook, A. H., Mark, L. A., Pinter-Brown, L., Hamid, O., Lin, B., Bian, Y., Boye, M., Day, J. M., & Rosen, S. T. (2011). Multicenter phase II trial of enzastaurin in patients with relapsed or refractory advanced cutaneous T-cell lymphoma. Leukemia and Lymphoma, 52(8), 1474-1480. https://doi.org/10.3109/10428194.2011.572265