Allos Therapeutics has announced interim results from an ongoing Phase I/II trial of PDX (pralatrexate) in patients with non-Hodgkin's lymphoma.
The trial was designed to determine the maximum tolerated dose (MTD), dose limiting toxicities and preliminary views of efficacy of PDX in patients with relapsed or refractory aggressive lymphomas. As part of the study, 16 patients were treated with PDX according to a dosing schedule of 135 mg/m2 of PDX every other week, with dose escalation for patients without significant toxicities. The protocol was amended in July 2004 to explore a weekly dosing schedule beginning at 30 mg/m2 for three weeks in a four week schedule. To date, 11 patients have been accrued to the amended Phase 1 study at dose levels up to 45 mg/m2, including seven patients with T-cell lymphoma. In total, eight patients with T-cell lymphoma have been treated with PDX, of whom five were evaluable for response.