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Allos Therapeutics Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of FOLOTYN in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Full Text
Allos Therapeutics, 03/04/2011
Allos Therapeutics, Inc. announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company's Phase 3 clinical trial of FOLOTYN in patients with previously undiagnosed peripheral T–cell lymphoma (PTCL). The study will seek to enroll newly diagnosed patients with PTCL who have achieved a response following initial treatment with a CHOP–based therapy.