RT Journal Article
T1 Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease.
A1 González-Barca, Eva
A1 Domingo-Domenech, Eva
A1 Capote, Francisco Javier
A1 Gómez-Codina, Jose
A1 Salar, Antonio
A1 Bailen, Alicia
A1 Ribera, Jose-María
A1 López, Andres
A1 Briones, Javier
A1 Muñoz, Andres
A1 Encuentra, Maite
A1 de Sevilla, Alberto Fernández
K1 Post-transplant lymphoproliferative disorders
K1 Rituximab
K1 Prognostic factors
K1 Anticuerpos monoclonales
K1 Estudios prospectivos
K1 Trastornos linfoproliferativos
K1 Trasplante de órganos
K1 Resultado del tratamiento
AB BACKGROUND AND OBJECTIVESThe 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 METHODSThis 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.RESULTSThirty-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 CONCLUSIONSThese 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.
PB Ferrata Storti Foundation
SN 0390-6078
YR 2007
FD 2007-11
LK http://hdl.handle.net/10668/1293
UL http://hdl.handle.net/10668/1293
LA en
NO González-Barca E, Domingo-Domenech E, Capote FJ, Gómez-Codina J, Salar A, Bailen A, et al. Prospective phase II trial of extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative disease. Haematologica. 2007; 92(11):1489-94
NO Clinical Trial, Phase II; Journal Article; Multicenter Study;
DS RISalud
RD Apr 11, 2025