A Phase 1 Multicenter Clinical Trial Of Alemtuzumab And Chop Chemotherapy For Peripheral T-Cell Lymphomas.

8551 Background: Alemtuzumab is an anti CD52 monoclonal antibody with single agent activity in relapsed peripheral T cell lymphomas (PTCL), but the optimal dose/schedule to combine with chemotherapy is unknown. Methods: The primary objectives of this phase 1 study were to establish the maximally tolerated dose (MTD) and pharmacokinetics (PK) of alemtuzumab combined with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) q21days. The MTD with highest trough levels would define the recommended phase II/III dose. Patient eligibility included: u003e age 18, untreated CD52+ PTCL, stage 2-4, measurable disease and adequate organ function. Alemtuzumab was given subcutaneously in 1 of 4 schedules using a 3+3 design with CHOP chemotherapy: 1) 10 mg day 1; 2) 10 mg weekly days 1, 8, 15; 3) 30 mg day 1; 4) 60 mg day 1. Trough PK were measured on day 1 of each 21d CHOP cycle. Results: 20 patients were enrolled; histology: AILD (n=7), PTCL NOS (n=6), ALK 1–ALCL (n=3), subpanniculitic (n=2), hepatosplenic (n=1) ...