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Pre-emptive treatment of acute GVHD: a randomized multicenter trial of rabbit anti-thymocyte globulin, given on day+7 after alternative donor transplants.

Author(s): Bacigalupo A, Lamparelli T, Milone G, Sormani MP, Ciceri F, Peccatori J, Locasciulli A, Majolino I, Di Bartolomeo P, Mazza F, Sacchi N, Pollicheni S, Pinto V, Van Lint MT, Gruppo Italiano Trapianto Midollo Osseo (GITMO)

Affiliation(s): Divisione Ematologia, Ospedale San Martino, Genova, Italy. andrea.bacigalupo@hsanmartino.it

Publication date & source: 2010-02, Bone Marrow Transplant., 45(2):385-91. Epub 2009 Jul 6.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

We have previously shown that hemopoietic stem cell transplant (HSCT) recipients can be stratified on day+7 as having low, intermediate or a high risk of transplant-related mortality (TRM). With the aim of reducing TRM and GVHD, intermediate and high-risk patients (n=170) were randomized to receive anti-thymocyte globulin (ATG, thymoglobuline) on day+7 (n=84) or no treatment (n=86) (controls). There was a reduction of TRM from 35% in controls to 29% in ATG patients (P=0.3), of acute GVHD III-IV from 15 to 5% (P=0.02) and of chronic GVHD from 26 to 11% (P=0.03); survival was comparable. The predictive value of the day+7 score on TRM was confirmed for controls (19 vs 42% for intermediate vs high risk, respectively, P=0.03), whereas ATG abrogated this predictive effect (29 vs 29%). ATG reduced GVHD (P=0.006) in high-risk patients, but not in patients with an intermediate risk. In conclusion, we confirm that TRM can be predicted on the basis of day+7 laboratory values, after alternative donor HSCT; in high-, but not intermediate-risk patients, the administration of ATG on day+7 reduces GVHD. These results may represent a platform for risk-adapted post transplant immune modulation.

Page last updated: 2010-10-05

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