NCT01204788.

Trial name or title	A prospective randomized comparative study of the effect on infections of radiated prophylactic white cell transfusions versus therapeutic radiated white cell transfusions (NCT01204788)
Methods	Allocation: Randomised. First 60 Endpoint Classification: Efficacy study Intervention Model: Parallel assignment Masking: Open label Primary Purpose: Prevention
Participants	Inclusion Criteria: Aged 2 years or older with a diagnosis of acute myelogenous leukaemia (including undifferentiated and bi‐phenotypic leukaemia), or high‐risk myelodysplastic syndrome, or chronic myelogenous leukaemia in blast crisis who will receive first or second anti‐leukaemia therapeutic intent with chemotherapy, targeted therapy or hypomethylating agents Exclusion Criteria: Patients with baseline (at start leukaemia treatment) infection, defined as patients with: fever and known positive cultures at the time of randomisation; or chest or sinus computed tomography with findings suggestive of pneumonia or sinusitis; or one positive galactomannan test >/= 1 or two positive galactomannan text >/= 0.5 to 1 Patients with Zubrod performance status >/= 3
Interventions	Prophylactic Arm ‐ Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion Therapeutic Arm ‐ Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion
Outcomes	Primary Outcome Measures: Number of patients with Infection (yes/no) where patient without infection found by day 42 patient are counted as 'No' to infection Secondary outcomes not reported on clinical trials website
Starting date	September 2010
Contact information	University of Texas MD Anderson Cancer Center Emil J Freireich
Notes	Study completion date January 2013