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Biol Blood Marrow Transplant. 2017 Jul;23(7):1102-1109. doi: 10.1016/j.bbmt.2017.03.031. Epub 2017 Apr 5.

Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas: Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen.

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Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. Electronic address:
Department of Hematology, University of Udine, Udine, Italy.
Department of Hematology, Azienda Ospedaliera Universitaria, Presidio Ospedaliero Ferrarotto, Catania, Italy.
Department of Hematology, Humanitas Cancer Center, Rozzano, Italy.
Department of Medical Statistics, Biometry and Bioinformatics, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Department of Hematology, Umberto I, Roma, Italy.
Department of Hematology, Ospedale San Gerardo Monza, Monza, Italy.
Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Department of Hematology, Ospedale di Alessandria, Alessandria, Italy.
Department of Transplantation, Azienda Ospedaliero-Univerisitaria Carreggi, Firenze, Italy.
Department of Stem Transplantation, Ospedale San Martino, Genova, Italy.
Department of Hematology, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy.
Department of Hematology, Universita' di Modena, Milan, Italy.
Department of Hematology, Ospedale Policlinico di Modena, Modena, Italy.
University of Milan, Hematology and Bone Marrow Transplant Unit, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
Division of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; Dept of Oncology, University of Milan, Milan, Italy.


The treatment of patients with refractory/relapsed B cell non-Hodgkin lymphoma (NHL) is evolving because of the availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and mortality remain a matter of concern. We conducted a multicenter prospective phase II trial to evaluate the benefit of including only 1 dose of rituximab in the conditioning regimen before alloSCT. The primary endpoint was progression-free survival. The study enrolled 121 patients with relapsed/refractory B cell lymphomas. The conditioning regimen consisted of thiotepa, cyclophosphamide, fludarabine, and rituximab (500 mg/m2). Rabbit antithymocyte globulin was administered only in case of unrelated donors. Sixty-seven (55%) and 54 (45%) patients received grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of nonrelapse mortality (NRM) was 21% at 3 years. The CCIs of chronic graft-verus-host disease (GVHD) at 3 years were 54% and 31% in recipients of matched sibling and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-year progression-free and overall survival were 50% and 61%, respectively. Long-term outcome was also evaluated with the composite endpoint of GVHD-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a prospective trial of lymphoma patients: the 1-year and 3-year GRFS were 40% and 34%, respectively. AlloSCT can cure a fraction of patients with rather low NRM and an encouraging PFS and GRFS.


Graft-versus-host disease–free/relapse-free survival; Lymphoma; Rituximab

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