Autologous Stem cell Transplantation (ASCT) in CLL. Results of a Phase III Randomized Multicenter Trial
(2009) 51st Annual Meeting of the American-Society-of-Hematology — Location: New Orleans (La) (5.December.2009)
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- Abstract
- Long-term responses have been reported after autologous stem cell transplantation (ASCT) for chronic lymphocytic leukemia (CLL). We conducted a prospective randomized trial of ASCT in previously untreated CLL patients. We enrolled 241 patients under 66 years of age with Binet stage B or C CLL. They first received 3 courses of mini-CHOP, then 3 courses of fludarabine. Patients in complete response (CR) were then randomized to ASCT or observation, while the other patients were randomized to DHAP salvage followed by either ASCT or 3 courses of fludarabine+cyclophosphamide. The primary endpoint was event-free survival (EFS). After up-front treatment 105 patients entered CR and were randomized between ASCT (n=52) and observation (n=53); their respective 3-year event-free survival (EFS) rates were 79.8% and 35.5%; the adjusted hazard ratio was 0.3 (95%CI: 0.1-0.7; p=0.003). Ninety-four patients who did not enter CR were randomized between ASCT (n=46) and FC (n=48); their respective 3-year EFS rates were 48.9% and 44.4%; the adjusted hazard ratio was 1.7 (95%CI: 0.9-3.2; p=0.13). No difference in OS was found between the two response subgroups. In young CLL patients in CR, ASCT consolidation markedly delayed disease progression. No difference was observed between ASCT and fludarabine+cyclophosphamide in patients requiring DHAP salvage.
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Sutton, L., Van Den Neste, E., Chevret, S., Maloum, K., Toumilhac, O., Divine, M., Leblond, V., Corront, B., Lepretre, S., Eghbali, H., Michallet, M., Maloisel, F., Bouabdallah, K., Berthou, C., Brice, P., Decaudin, D., Gonzalez, H., Khac, F. N., Davi, F., et al. (2009). Autologous Stem cell Transplantation (ASCT) in CLL. Results of a Phase III Randomized Multicenter Trial. Blood, 114(22), 361-362. https://hdl.handle.net/2078.5/232065 (Original work published 2009)