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

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 receiv...

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Published in:Bone marrow transplantation (Basingstoke) Vol. 45; no. 2; pp. 385 - 391
Main Authors: Bacigalupo, A, Lamparelli, T, Milone, G, Sormani, M P, Ciceri, F, Peccatori, J, Locasciulli, A, Majolino, I, Di Bartolomeo, P, Mazza, F, Sacchi, N, Pollicheni, S, Pinto, V
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 01-02-2010
Nature Publishing Group
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Summary: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.
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ISSN:0268-3369
1476-5365
DOI:10.1038/bmt.2009.151