A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.
Availability of suitably matched unrelated donor (9/10 or 10/10)
Fludarabine-Melphalan (Fludarabine 120-180mg/m2 IV; melphalan ≤ 150mg/m2 IV)
BEAM or LEAM (carmustine 300mg/m2 IV or lomustine 200mg/m2 IV with: etoposide 800 mg/m2 IV; cytarabine 1600mg/m2 IV; melphalan 140mg/m2 IV)
Fludarabine-Busulphan (Fludarabine 120-180mg/m2 IV; Busulphan ≤ 8mg/kg PO or 6.4mg/kg IV)
Use of any method of graft manipulation (excluding storage of future DLI)
Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined
Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
Pregnant or lactating women
University of Birmingham
Lead sponsor
The Jon Moulton Charity Trust
Collaborator
IMPACT (funded by NHS Blood & Transplant, Anthony Nolan and Leukaemia UK)
Collaborator