We report the preliminary results of a prospective randomized study on
the impact of two different dosages of Cyclosporine A (Cs-A) on proba
bility of development of acute and chronic GVHD, transplant-related mo
rtality (TRM), relapse rate (RR) and event-free survival (EFS). Fifty-
nine pediatric patients given BMT from an HLA-identical sibling were c
entrally randomized to receive either Cs-A at a dosage of 1 mg/kg/die
(CsA1) or at a dosage of 3 mg/kg/die (CsA3) intravenously for the firs
t 21 days after BMT, Patients given Cs-A at a dosage of 1 mg/kg/die ha
d a higher probability of developing acute GVHD, but a lower relapse r
ate, which translated into a better probability of EFS.These prelimina
ry results to be confirmed with a longer follow-up suggest that the us
e of low doses of CsA is feasible even though associated with a higher
incidence of GVHD, but without any increment in TRM, The reduction of
immunosuppressive treatment after BMT favoured the development of a g
raft-versus-leukemia effect, which seems to play a relevant role in pr
eventing leukemia recurrence and in improving the cure rate.