Allos Therapeutics has recruited first patient in a Phase 3 multi-center, randomized, open-label (PDX-017) Phase 2 trial investigating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). Folotyn is approved in the US as a treatment for the patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).The study aims to determine the efficacy and safety of equential Folotyn versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with CHOP or a CHOP-like regimen.
Currently, the study is open to recruit newly diagnosed PTCL patients who have achieved an objective response following initial treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen.
