Pilot Study of partially Human Leucocyte Antigen (HLA)-mismatched stem cell infusions after chemotherapy for acute myeloid leukaemia in patients over the age of 60.

Infusion of Granulocyte Colony Stimulating Factor (G-CSF) mobilised Peripheral Blood Stem Cells (PBSCs) from a partially HLA-mismatched relative after standard induction and consolidation chemotherapy for patient with Acute Myeloid Leukaemia greater than 60 yrs of age. PBSCs will be harvested by apheresis from the donor on day 9 (of induction chemotherapy for the patient) after administration of GCSF to the donor(10 micrograms/kg subcutaneously daily from days 5 to 8). The minimum stipulated CD34 positive cell dose will be greater than 0.5 x 10^6/kg. The total collection will be divided into 4 aliquots: 3 portions will be cryopreserved for later use and one portion will be infused into patient on the day of collection (day 9). Induction therapy will consist of 7+3 regimen with continuous Cytarabine (150mg/m2) intravenous infusion for 7 days and Mitoxantrone (10mg/m2) intravenously daily for 3 days, followed by intravenous infusion of GCSF mobilised PBSCs on day 9. Bone marrow biopsy will be performed by day 28 +/- 7 days and if complete remission is confirmed patients will proceed with consolidation chemotherapy. If patient is not in morphologic complete remission then a further cycle of induction followed by PBSC infusion is offered. If the patient is in remission following induction, 2 cycles of consolidation chemotherapy, comprising the 5 + 2 regimen (Mitoxantrone 10mg/m2 IV days 1 to 2 and Cytarabine 150mg/m2 continuous IV infusion days 1 to 5) will be delivered and each cycle will be followed by IV infusion of PBSCs, 36 to 48 hours after chemotherapy has been disconnected. All of the above treatments are part of the study intervention.