“Therapies currently used to treat cutaneous T-cell lymphoma fail to produce durable remissions in the majority of patients with advanced disease,” said Pablo Cagnoni, chief medical officer of Allos.
In this study, patients with either relapsed or refractory cutaneous T- cell lymphoma (CTCL) will receive PDX, a novel antifolate with vitamin B12 and folic acid supplementation, as part of a weekly schedule for two or three weeks followed by one week of rest.
Patients will receive starting doses of PDX at 30mg/m2, with dose reduction in subsequent cohorts based on toxicity. Up to 56 evaluable patients will be enrolled in the study with the objective of determining the optimal dose and safety profile of PDX in this population. A total of 20 of these patients will be enrolled at what is determined to be the optimal dose and schedule.
“Given the evidence of activity observed to date with PDX in patients with aggressive T-cell lymphomas, coupled with the common cell lineage between PTCL and CTCL, there is a strong clinical rationale to pursue development of PDX in this setting,” said Steven Horwitz, assistant attending physician will serve as the study chair.