Feasibility and Efficacy of High Doses of Antimetabolites Followed by High-Dose Sequential Chemoimmunotherapy (R-Hds) and Autologous Stem Cell Transplant (asct) in Patients (pts) with Systemic B-Cell Lymphoma (bcl) and Central Nervous System (cns) Involvement: A Multicenter Phase Ii Trial.

8577 Background: This is a phase II trial addressing a new treatment in pts with BCL and CNS disease (NCT00801216). Treatment is based on the encouraging experiences with high doses of antimetabolites in pts with primary CNS lymphoma (Ferreri et al. Lancet 2009) and with R-HDS/ASCT in pts with relapsed BCL (Tarella et al.JCO 2008). Methods: HIV- pts (18-70 ys; ECOG PS ≤3) with BCL and CNS disease at diagnosis or relapse were treated with 2 c. of methotrexate 3.5 g/m2 d1 + cytarabine 2 g/m2 x2/d d2-3, followed by R-HDS (cyclophosphamide 7 g/m2 d1, cytarabine 2 g/m2 x2/d d22-25, VP16 2 g/m2 d43) and BCNU-thiotepa conditioning + ASCT. Treatment included 8 doses of rituximab and 4 of intrathecal liposomal cytarabine. Primary endpoint: 2-yr PFS; planned accrual: 38 pts. Results: 40 pts were registered (age 32-70 ys, median 59; M/F ratio 1.5): 34 had DLBCL, 3 MCL blastoid variant, 3 FL. CNS disease (brain 23, meninges 6, spinal cord 2, multiple 9) was detected at diagnosis in 17 pts (all with extra-CNS disease)...