Rituximab prophylaxis prevents corticosteroid-requiring chronic GVHD after allogeneic peripheral blood stem cell transplantation: results of a phase 2 trial.

Journal Article (Journal Article)

B cells are implicated in the pathophysiology of chronic graft-vs-host disease (GVHD), and phase 2 trials suggest that B cell depletion can treat established chronic GVHD. We hypothesized that posttransplantation B cell depletion could prevent the occurrence of chronic GVHD. We performed a 65-patient phase 2 trial of rituximab (375 mg/m(2) IV), administered at 3, 6, 9, and 12 months after transplantation. Rituximab administration was safe without severe infusional adverse events. The cumulative incidences of chronic GVHD and systemic corticosteroid-requiring chronic GVHD at 2 years from transplantation were 48% and 31%, respectively, both lower than the corresponding rates in a concurrent control cohort (60%, P = .1, and 48.5%, P = .015). There was no difference in relapse incidence, but treatment-related mortality at 4 years from transplantation was significantly lower in treated subjects when compared with controls (5% vs 19%, P = .02), and overall survival was superior at 4 years (71% vs 56%, P = .05). At 2 years from transplantation, the B-cell activating factor/B-cell ratio was significantly higher in subjects who developed chronic GVHD in comparison with those without chronic GVHD (P = .039). Rituximab can prevent systemic corticosteroid-requiring chronic GVHD after peripheral blood stem cell transplantation and should be tested in a prospective randomized trial.

Full Text

Duke Authors

Cited Authors

  • Cutler, C; Kim, HT; Bindra, B; Sarantopoulos, S; Ho, VT; Chen, Y-B; Rosenblatt, J; McDonough, S; Watanaboonyongcharoen, P; Armand, P; Koreth, J; Glotzbecker, B; Alyea, E; Blazar, BR; Soiffer, RJ; Ritz, J; Antin, JH

Published Date

  • August 22, 2013

Published In

Volume / Issue

  • 122 / 8

Start / End Page

  • 1510 - 1517

PubMed ID

  • 23861248

Pubmed Central ID

  • PMC3750344

Electronic International Standard Serial Number (EISSN)

  • 1528-0020

Digital Object Identifier (DOI)

  • 10.1182/blood-2013-04-495895


  • eng

Conference Location

  • United States