HLA-Epitope
HLA epitope matched platelet transfusion in aplastic anaemia, myelodysplastic syndromes diseases (MDS) and acute myeloid leukemia (AML) patients
The HLA-Epitope study is now complete.
Chief investigators: Prof Judith Marsh and Dr Cristina Navarette
Primary sponsor: NHSBT
Funder: NHSBT
Summary
A comparison of HLA epitope-matched (HEM) with standard HLA-matched prophylactic platelet transfusions in raising the platelet count increment in alloimmunised thrombocytopenic patients with aplastic anaemia, myelodysplastic syndrome or acute myeloid leukaemia. A double-blind randomised cross-over trial.
Study hypothesis
It is hypothesised that the HEM matching method will result in a higher platelet count increment. However, for implementation, it is important to show that this new method does not result in an unacceptably lower platelet count increment and therefore a non-inferiority approach is used for the design and sample size calculation.
Study design
This is a double-blind, randomised, crossover trial designed to compare the effect of HLA epitope-matched (HEM) with standard HLA-matched (HSM) prophylactic platelet transfusions in raising the platelet count increment after transfusion in alloimmunised thrombocytopenic patients with aplastic anaemia (AA), myelodysplasia (MDS), or acute myelodysplastic leukaemia (AML).
HEM platelets will be selected using the HLAMatchmaker epitope matching programme. Patients will be randomised to receive five pairs of HEM and HSM platelet transfusions in random order. Patients, treating clinicians and clinical staff will be blinded to the type of platelets patients receive. Blinding will be maintained by ensuring that both HEM and HSM platelets are in identical standard packages and have identical standard labels.
The NHSBT H&I issuing laboratory will assign the randomised treatment schedule, thus the H&I laboratory staff will not be blinded. Each NHSBT H&I issuing laboratory computer will hold a list of study numbers and corresponding randomised treatment schedule assigned to each study number.
Publications
Marsh JCW, Kallon D, Brown C, Gilbertson A, Pigden C, Deary AJ, Mora A, Brown J, Laing E, Pankhurst L, Choo L, Hodge R, Llewelyn C, Harding K, Sage D, Mijovic A, Mufti GJ, Stanworth SJ, Navarrete CV. National randomised trial of HLA epitope matched platelet transfusions for alloimmunised patients with myeloid bone marrow disorders. British Blood Transfusion Society Meeting November 11th 2015
JCW Marsh, D Kallon, C Brown, C Pigden, A Deary, K Harding, L Choo, C LLewelyn, A Mijovic, GJ Mufti, S Stanworth, C Navarrete. Application of HLAMatchmaker computer programme to select HLA epitope matched platelets for alloimmunised thrombocytopenic patients with aplastic anaemia, MDS and acute myeloid leukaemia. British Haematological Society Annual Scientific Meeting 2014
C Pigden and D Kallon HLA-Epitope: Trial of HLA epitope-matched platelets in patients with aplastic anaemia, myelodysplastic syndrome and acute myeloid leukaemia. On behalf of the TMG of the HLA Epitope Trial. Blood and Transplant Matters October 2014