TY - JOUR AU - Eva González-Barca, AU - Eva Domingo-Domenech, AU - Francisco Javier Capote, AU - Jose Gómez-Codina, AU - Antonio Salar, AU - Alicia Bailen, AU - Jose-María Ribera, AU - Andres López, AU - Javier Briones, AU - Andres Muñoz, AU - Maite Encuentra, AU - Alberto Fernández de Sevilla, PY - 2007/10/31 Y2 - 2024/03/29 TI - Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease JF - Haematologica JA - haematol VL - 92 IS - 11 SE - Articles DO - 10.3324/haematol.11360 UR - https://haematologica.org/article/view/4629 SP - 1489-1494 AB - 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 II 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. ER -