Bortezomib-based immunosuppression after reduced-intensity conditioning hematopoietic stem cell transplantation: randomized phase II results.

Bortezomib-based immunosuppression after reduced-intensity conditioning hematopoietic stem cell transplantation: randomized phase II results. Haematologica. 2018 Jan 11;: Authors: Koreth J, Kim HT, Lange PB, Poryanda SJ, Reynolds CG, Chamling Rai S, Armand P, Cutler CS, Ho VT, Glotzbecker B, Yusuf R, Nikiforow S, Chen YB, Dey B, McMasters M, Ritz J, Blazar BR, Soiffer RJ, Antin JH, Alyea EP Abstract A prior phase I/II trial of bortezomib/tacrolimus/methotrexate prophylaxis after HLA-mismatched reduced intensity conditioning allogeneic hematopoietic stem cell transplantation documented low acute graft versus host disease incidence, with promising overall and progression-free survival. We performed an open-label 3-arm 1:1:1 phase II randomized-controlled-trial comparing grade II-IV acute graft versus host disease between conventional tacrolimus/methotrexate (A) versus bortezomib/tacrolimus/methotrexate (B); and versus bortezomib/sirolimus/tacrolimus (C), in reduced intensity conditioning allogeneic transplantation recipients lacking HLA-matched related donors. Primary endpoint was grade II-IV acute graft versus host disease incidence rate by day+180. 138 patients (A 46, B 45, C 47) with median age 64 years (range, 24-75), varying malignant diagnoses and disease risk (Low 14, Intermediate 96, High/Very High 28) received 7-8/8 HLA-mismatched (40) or matched unrelated donor (98) grafts. Median follow-up in survivors was 30 months (range, ...
Source: Haematologica - Category: Hematology Authors: Tags: Haematologica Source Type: research