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 language | English (US) |
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Pages (from-to) | 1474-1480 |
Number of pages | 7 |
Journal | Leukemia and Lymphoma |
Volume | 52 |
Issue number | 8 |
DOIs | |
State | Published - 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