None listed
Conditions
Brief summary
This study aims to determine the effect of partially HLA-mismatched stem cell infusions after chemotherapy for acute myeloid leukaemia in older patients. Who is it for? You may be eligible to join this study if you are aged between 60-85 years and have been diagnosed with acute myeloid leukaemia (AML) which has been previously untreated. You should be undergoing induction chemotherapy and have an available partially HLA-mismatched donor. Trial details: All participants in this trial will undergo standard induction chemotherapy. Peripheral blood stem cells (PBSCs) will be collected from the available donor, then harvested and administered to the patient on day 9 of induction chemotherapy by intravenous infusion (i.e. directly into the vein). On day 28 a bone marrow biopsy will be performed, and if complete remission is confirmed then patients will proceed with two cycles of consolidation chemotherapy. If the patient is not in complete remission then a further cycle of induction chemotherapy followed by PBSC infusion is offered. Participants will be regularly assessed for up to 24 months in order to determine clinical efficacy and safety of the treatment.
Interventions
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 CD3
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.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients aged over 60 with previously untreated AML undergoing induction chemotherapy, who have an available partially HLA-mismatched donor
Exclusion criteria
Patient with Acute Promyelocytic Leukaemia, Chronic Myeloid Leukaemia or unfit for induction chemotherapy or have immunodeficiency (apart from neutropenia)
Outcome results
None listed