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Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease González Barca, Eva Domingo Domènech, Eva Capote, Francisco Javier Gómez Codina, Jose Salar, Antonio Bailen, Alicia Ribera, Josep Maria López, Andres Briones, Javier Muñoz, Andres Encuentra, Maite Fernández de Sevilla Ribosa, Alberto GELTAMO (Grupo Español de Linfomas y Trasplantes de Médula Ósea) GELCAB (Grupo para el Estudio de los Linfomas Catalano-Balear) GOTEL (Grupo Oncológico para el Tratamiento y Estudio de los Linfomas) Limfomes Malalties hematològiques Pronòstic mèdic Terapèutica Lymphomas Hematologic diseases Prognosis Therapeutics Background and Objectives The elective treatment of patients with post-transplant lymphoproliferative disorders is controversial. The purpose of this trial was to evaluate the efficacy of treatment with extended doses of rituximab adapted to the response in patients with post-transplant lymphoproliferative disorders after solid organ transplantation. Design and Methods This was a prospective, multicenter, phase 11 trial. Patients were treated with reduction of immunosuppression and four weekly infusions of rituximab. Those patients who did not achieve complete remission (CR) received a second course of four rituximab infusions. The primary end-point of the study was the CR rate. Results Thirty-eight patients were assesable. One episode of grade 4 neutropenia was the only severe adverse event observed. After the first course of rituximab, 13 (34.2%) patients achieved CR, 8 patients did not respond, and 17 patients achieved partial remission. Among those 17 patients, 12 could be treated with a second course of rituximab, and 10 (83.3%) achieved CR, yielding an intention-to-treat CR rate of 60.5%. Eight patients excluded from the trial because of absence of CR were treated with rituximab combined with chemotherapy, and six (75%) achieved CR. Event-free survival was 42% and overall survival was 47% at 27.5 months. Fourteen patients died, ten of progression of their post-transplant lymphoproliferative disorder. Interpretation and Conclusions These results confirm that extended treatment with rituximab can obtain a high rate of CR in patients with post-transplant lymphoproliferative disorders after solid organ transplantation without increasing toxicity, and should be recommended as initial therapy for these patients. 2019-01-25T08:51:06Z 2019-01-25T08:51:06Z 2007 2019-01-25T08:51:06Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 0390-6078 https://hdl.handle.net/2445/127596 557804 eng Reproducció del document publicat a: https://doi.org/10.3324/haematol.11360 Haematologica, 2007, vol. 92, num. 11, p. 1489-1494 https://doi.org/10.3324/haematol.11360 cc-by-nc (c) Ferrata Storti Foundation, 2007 http://creativecommons.org/licenses/by-nc/3.0/es info:eu-repo/semantics/openAccess 6 p. application/pdf Ferrata Storti Foundation Articles publicats en revistes (Ciències Clíniques)