A phase I/II trial of clofarabine in patients with relapsed T-cell or NK-cell lymphomas.

8046 Background: Peripheral T-cell lymphomas (PTCL) are a heterogeneous and poor prognostic subset of non-Hodgkin's lymphoma. Clofarabine is a nucleoside analog which blocks DNA synthesis via inhibition of ribonucleotide reductase and DNA polymerases, and induces apoptosis. In early phase trials, complete responses (CR) were seen among patients with T/NK-cell lymphomas treated with clofarabine. Methods: In 2006, we began a phase I/II trial to examine the use of clofarabine in patients with relapsed and refractory T or NK lymphomas. The objective of the phase I portion was to identify the maximum tolerated dose (MTD) and determine its toxicities. The phase I portion started at a dose of 4 mg/m2 iv for 3 consecutive days every 3 weeks. The cohort was expanded at the MTD. Results: 29 patients (median age was 54; range, 23-82) have been enrolled. The trial will be closed to accrual in 2 months. The most common histologies include: PTCL-NOS (n=8), transformed mycosis fungoides (tMF) (n=5), ALK- anaplastic larg...