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Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma
Journal of Clinical Oncology, 10/20/09

Piekarz RL et al. – The histone deacetylase inhibitor romidepsin has single-agent clinical activity with significant and durable responses in patients with CTCL.

Methods

Initial cohort was limited to patients with cutaneous T-cell lymphoma (CTCL), or subtypes mycosis fungoides or Sézary syndrome, who had received no more than 2 prior cytotoxic regimens
No limits on other types of therapy
Protocol expanded to enroll patients who received more than 2 prior cytotoxic regimens

Results

27 patients enrolled onto first cohort, and total of 71 patients are included in analysis
Patients had undergone median of 4 prior treatments, and 62 patients (87%) had advanced-stage disease
Toxicities included nausea, vomiting, fatigue, and transient thrombocytopenia and granulocytopenia
Pharmacokinetics evaluated with first administration of romidepsin
Complete responses observed in 4 patients, and partial responses were observed in 20 patients for overall response rate of 34%