A Phase ‘2-1-2’ study of two different doses and schedules of pralatrexate, a high affinity substrate for the reduced folate carrier (RFC-1), in patients with relapsed or refractory lymphoma reveals marked activity in T-cell malignancies

Purpose To determine the maximum-tolerated dose (MTD) and efficacy of pralatrexate in patients with lymphoma. Patients and Methods Pralatrexate, initially given at a dose of 135 mg/m 2 on an every-other-week basis, was associated with stomatitis. A redesigned, weekly phase I/II study established an MTD of 30 mg/m 2 weekly for six weeks every 7 weeks. Patients were required to have relapsed/refractory disease, an absolute neutrophil greater than 1,000/L, and a platelet count greater than 50,000/L for the first dose of any cycle. Results