Randomized study of rituximab in patients with relapsed or resistant follicular lymphoma prior to high-dose therapy as in vivo purging and to maintain remission following high-dose therapy.

8005 Background: To evaluate the effects of in vivo purging with rituximab 375 mg/m2 weekly × 4 (RP) and maintenance rituximab 375 mg/m2 every 3 months for 2 years (RM) on progression free survival (PFS) in patients with relapsed follicular NHL (rFL) undergoing high-dose therapy with BEAM conditioning. Methods: From Oct 1999 to Apr 2006, 280 of a planned 420 patients with rFL in first (n=16), second (n= 222) or third remission (n=41) who achieved either a complete remission (n=83) or a very good partial remission (n=196) to induction chemotherapy, with limited bone marrow infiltration (<25% B-lymphocytes) underwent a single randomisation in a 2x2 design to RP and RM, n = 69; RP, n = 72; RM, n = 69; No R n = 70. Results: PFS at 5 years was 54.3% versus 47.8% for in vivo purging versus none (logrank PFS; p=0.20; HR 1.23, 95%CI: 0.89 - 1.72). PFS at 5 years was 58.8% versus 42.6% in patient receiving R maintenance versus none (logrank PFS; p=0.02; HR 1.50, 95%CI: 1.07 - 2.09). PFS at 5 years was 54.8% versus...