Steroid treatment of acute graft--host disease grade I: a randomized trial.

Patients with acute graft--host disease (GvHD) grade I were randomized to an observation arm (n=85) or to a treatment arm (n=86) consisting of 6-methylprednisolone 1 mg/kg/day, after stratification for age and donor type. The primary end point was development of grade II-IV GvHD. The cumulative incidence of grade II-IV GvHD was 50% in the observation arm and 33% in the treatment arm (=0.005). However, grade III-IV GvHD was comparable (13% 10%, respectively; =0.6), and this was true for sibling and alternative donor transplants. Moderate/severe chronic GvHD was also comparable (17% 9%). In multivariate analysis, an early interval between transplant and randomization (