Three prophylaxis regimens (tacrolimus, mycophenolate mofetil, and cyclophosphamide; tacrolimus, methotrexate, and bortezomib; or tacrolimus, methotrexate, and maraviroc) versus tacrolimus and methotrexate for prevention of graft-versus-host disease with haemopoietic cell transplantation with reduced-intensity conditioning: a randomised phase 2 trial with a non-randomised contemporaneous control group (BMT CTN 1203)

Publication date: March 2019Source: The Lancet Haematology, Volume 6, Issue 3Author(s): Javier Bolaños-Meade, Ran Reshef, Raphael Fraser, Mingwei Fei, Sunil Abhyankar, Zaid Al-Kadhimi, Amin M Alousi, Joseph H Antin, Sally Arai, Kate Bickett, Yi-Bin Chen, Lloyd E Damon, Yvonne A Efebera, Nancy L Geller, Sergio A Giralt, Parameswaran Hari, Shernan G Holtan, Mary M Horowitz, David A Jacobsohn, Richard J JonesSummaryBackgroundPrevention of graft-versus-host disease (GvHD) without malignant relapse is the overall goal of allogeneic haemopoietic cell transplantation (HCT). We aimed to evaluate regimens using either maraviroc, bortezomib, or post-transplantation cyclophosphamide for GvHD prophylaxis compared with controls receiving the combination of tacrolimus and methotrexate using a novel composite primary endpoint to identify the most promising intervention to be further tested in a phase 3 trial.MethodsIn this prospective multicentre phase 2 trial, adult patients aged 18–75 years who received reduced-intensity conditioning HCT were randomly assigned (1:1:1) by random block sizes to tacrolimus, mycophenolate mofetil, and post-transplantation cyclophosphamide (cyclophosphamide 50 mg/kg on days 3 and 4, followed by tacrolimus starting on day 5 and mycophenolate mofetil starting on day 5 at 15 mg/kg three times daily not to exceed 1 g from day 5 to day 35); tacrolimus, methotrexate, and bortezomib (bortezomib 1·3 mg/m2 intravenously on days 1, 4, and 7 after HCT); or tacrolimus...
Source: The Lancet Haematology - Category: Hematology Source Type: research