1Department of Hematology and Cellular Therapy, Haut-Leveque University Hospital, Bordeaux2Department of Hematology, Institut Paoli Calmettes, Marseille3Methodological Support Unit in Clinical and Epidemiological Research (USMR), University Hospital, Bordeaux4Department of National Health Institute and Medical Research (INSERM U897, CIC-EC7), Bordeaux5Department of Hematology, University Hospital, Nantes6Department of Hematology, University Hospital, Clermont-Ferrand7Department of Hematology, University Hospital, Montpellier8Medical School Department, Bordeaux Segalen University, Bordeaux9Department of Hematology, Saint-Antoine University Hospital, Paris10Department of National Health Institute and Medical Research (INSERM, UMR 892), Team 10, Nantes, France
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BackgroundPatients with advanced B-cell non-Hodgkin's lymphoma (NHL) refractory to initial chemotherapy or relapsing after autologous stem-cell transplantation have a poor prognosis. Allogeneic stem-cell transplantation after reduced-intensity conditioning (RIC) regimen can be a therapeutic option. However, the high incidence of relapse remains a challenging issue. We speculated that the incorporation of 90Y-Ibritumomab tiuxetan into a fludarabine-based RIC regimen would improve the lymphoma control without overwhelming toxicity. Our aim was to evaluate the safety of 90Y-Ibritumomab tiuxetan in association with such a regimen in a prospective multicenter phase II trial.Patients and methodsThirty-one patients with advanced lymphoma from five distinct institutions were included between February 2008 and October 2010. Thirty patients in complete or partial response after failure of a median of 3 (range, 2–4) previous chemotherapy regimens including autologous transplant in 29 were evaluable for nonrelapse mortality (NRM) at day 100 post-transplant that was the primary end point.ResultsWith a median follow-up of 32 months (range, 29–60 months), the 2-year event-free and overall survivals of the whole study group were both 80% [95 confidence interval (CI) 60.8% to 90.5%). The 100-day and 2-year post-transplant cumulative incidences of NRM were 3.3% (95% CI 0.2% to 14.9%) and 13.3% (95% CI 5.4% to 33.2%), respectively. The 2-year cumulative incidence of relapse was 6.7% (95% CI 1.7% to 25.4%). The cumulative incidences of grade II–IV and extensive chronic graft-versus-host disease were 27% and 14%, respectively.ConclusionsFor chemosensitive advanced high-risk B-cell lymphoma, the addition of 90Y-Ibritumomab tiuxetan to a RIC regimen based on fludarabine, busulfan and antithymocyte globulin followed by allogeneic transplant is safe and highly effective.clinicaltrials.gov: NCT00607854.