A Phase III Study Comparing Low Dose Cyclosporine, Methotrexate And Prednisone Versus Standard Dose Cyclosporine and Methotrexate As Graft Versus Host Disease Prophylaxis In Myeloblative Allogeneic Stem Cell Transplantation (ALLG BM10 trial). (Incorporating an Open-Label Sub-study Investigating The Use Of Valganciclovir In The Prevention Of Cytomegalovirus Infection In Hematopoietic Stem Cell Transplant Recipients (ML20712))

Stem cell transplantation has the potential to cure many patients with blood cancers. These cures occur when immune cells from the donor attack blood cancer cells left in the patient. This is called the graft versus leukaemia (GVL) effect. These immune cells also cause a reaction against the patient called graft versus host disease (GVHD), which can be serious and life threatening. Thus, one of the major goals of transplantation today is is to reduce GVHD and increase GVL. The drugs cyclosporine and prednisone are used to reduce graft versus host disease in over 90% of transplants performed in Australia and New Zealand. The aim of this study is to reduce the dose of cyclosporine which may increase the GVL effect and add a higher dose of prednisone which may inhibit GVHD – this is the intervention. This new combination of these two drugs will be compared to the standard dose of cyclosporine which has been used for many years – this will be the control group. Patients will be followed for 2 years to assess whether this change in drugs will result in more patients being cured of their blood cancers.