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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

31 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 (US)
Pages (from-to)1474-1480
Number of pages7
JournalLeukemia and Lymphoma
Volume52
Issue number8
DOIs
StatePublished - Aug 2011

Funding

This study was sponsored by Eli Lilly and Company and its subsidiaries. Medical writing support was provided by Lori Kornberg of i3 Statprobe (Ann Arbor, MI), with whom Eli Lilly and Company contracted for technical writing. The authors wish to acknowledge the patients, their families, and the study personnel who participated in this clinical trial.

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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