Population
Adult patients with a haematological malignancy receiving first allogeneic haematopoietic stem cell transplantation (n= 157).
Intervention
Prophylactic extracorporeal photopheresis (ECP), (intervention group, n= 76).
Comparison
No ECP (control group, n= 81).
Outcome
During the first year, 45 patients in the intervention and 52 control patients developed graft-versus-host disease (GVHD), (HR= 0.82, 95% CI [0.55, 1.22]). There were no differences in acute or chronic GVHD or its organ distribution in this intention-to-treat randomised controlled trial. A per-protocol analysis revealed a significant difference in GVHD between the intervention (per-protocol; n= 39 of 76) and the control group (n= 77), 46% vs. 68%, respectively, (HR 0.47, 95% CI [0.27, 0.80]). Relapse occurred in 15 patients in the intervention group and in 11 control patients (HR= 1.38, 95% CI [0.64, 3.01]). GVHD-free relapse-free survival, event-free survival, overall survival and non-relapse mortality did not differ significantly between the two study groups. There also was no significant difference in immune reconstitution between the two groups.