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Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: A randomised, open-label, multicentre phase 3 trial
The Lancet Oncology - Online First, 08/24/09

Finke J et al. – Study concludes that the addition of anti-T-cell globulins-Fresenius (ATG-F) to graft-versus-host disease (GVHD) prophylaxis with ciclosporin and methotrexate (MTX) resulted in decreased incidence of acute and chronic GVHD without an increase in relapse or non-relapse mortality, and without compromising overall survival.

Methods

Phase 3 trial to compare standard GVHD prophylaxis with ciclosporin and MTX with or w/o anti-Jurkat ATG-F
202 pts with haematological malignancies; randomly assigned between treatment groups receiving ciclosporin and MTX with or w/o additional ATG-F
1 patient in the ATG-F group did not undergo transplantation
Thus 201 pts who underwent transplantation with peripheral blood or bone marrow grafts from unrelated donors were included
Primary endpoint was severe acute GVHD (aGVHD) grade III-IV or death within 100 days of transplantation

Results

No. of pts in ATG-F group who had severe aGVHD grade III-IV or who died within 100 days of transplantation was 12 and 10 respectively, vs 24 and 9 pts, respectively, in control group
Cumulative incidence of aGVHD grade III-IV was 11·7% in ATG-F group vs 24·5% in control group
Cumulative incidence of aGVHD grade II-IV was 33·0% in ATG-F group vs 51·0% in control group
The 2-year cumulative incidence of extensive chronic GVHD was 12·2% vs 42·6%
No differences between treatment groups with regard to relapse, non-relapse mortality, overall survival, and mortality from infectious causes

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