None listed
Conditions
Brief summary
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.
Interventions
Randomised trial of graft versus host disease prophylaxis: Study Intervention – Reduction of cyclosporine (to 1mg/kg intravenously D-1 to D+15 post transplant) followed by oral cyclosporine targeted at 100-200 ug/l until D110 and addition of prednisone (orally from D16 to D110 commencing at 0.5mg/kg/day).
Prevention Of Cytomegalovirus (CMV) Infection substudy. A phase II study assessing the use of valganciclovir in stem cell transplant recipients to prevent and treat CMV infection. Valganciclo
Randomised trial of graft versus host disease prophylaxis: Study Intervention – Reduction of cyclosporine (to 1mg/kg intravenously D-1 to D+15 post transplant) followed by oral cyclosporine targeted at 100-200 ug/l until D110 and addition of prednisone (orally from D16 to D110 commencing at 0.5mg/kg/day). Prevention Of Cytomegalovirus (CMV) Infection substudy. A phase II study assessing the use of valganciclovir in stem cell transplant recipients to prevent and treat CMV infection. Valganciclovir 900mg will be continued until D100. CMV viraemia and disease will be assessed until 6 months post transplant with the primary endpoint being the incidence of CMV infection at 6 months.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
2. Presence of a haematological malignancy, for which myeloblative allogeneic haematopoietic stem cell transplant is considered appropriate therapy.3. Disease status: acute myeloblastic leukaemia, acute lymphoblastic leukaemia (ALLG), Philadelphia positive ALL in first or later complete remission, chronic myeloid leukaemia (CML), multiple myeloma, non-hodgkin’s lymphoma, Hodgkin’s lymphoma in first or later complete remission, myelodisplastic syndrome. Myelofibrosis and other haematological malignancies are also included. 4. Ability to give informed consent.5. Preserved functional status (Eastern Cooperative Oncology Group performance status <2).6. Left ventricular ejection fraction > 45%. 7. Diffusing capacity of the lung for carbon monoxide > 50% of normal on pulmonary function testing.8. Serum Creatinine <150 umol/L9. Serum Bilirubin < 40mmol/l, AST < 3 x upper limit of normal.10. Availability of a willing, 7/8 or 8/8 human leukocyte antigens (HLA) -matched sibling or unrelated stem cell donor matched at HLA A, B, C and DRB1 (One antigen mismatch at Class I is permissible if no other suitable donor is available).11. Ability to harvest > 2.0 x 106/kg CD34 peripheral blood stem cells.
Exclusion criteria
1. Human immunodeficiency virus sero-positive2. Life expectancy less than 3 months.3. Psychiatric condition preventing the patient from providing informed consent.4. Pregnant or lactating women.5. History of active malignant disease within the previous 5 years excluding basal cell carcinoma or sqamous cell carcinoma of the skin.6. Previous allogeneic stem cell transplant7. More than 2 previous autografts
Outcome results
None listed