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

Corey Cutler, Haesook T. Kim, Bhavjot Bindra, Stefanie Sarantopoulos, Vincent T. Ho, Yi Bin Chen, Jacalyn Rosenblatt, Sean McDonough, Phandee Watanaboonyongcharoen, Philippe Armand, John Koreth, Brett Glotzbecker, Edwin Alyea, Bruce R. Blazar, Robert J. Soiffer, Jerome Ritz, Joseph H. Antin

Research output: Contribution to journalArticlepeer-review

81 Scopus citations

Abstract

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/m2 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. This trial was registered at www.clinicaltrials. gov as NCT00379587.

Original languageEnglish (US)
Pages (from-to)1510-1517
Number of pages8
JournalBlood
Volume122
Issue number8
DOIs
StatePublished - Aug 22 2013

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