A randomised feasibility n-of-1 trial of weekly-interval red cell transfusion myelodysplastic syndromes

Monash University0 个研究点目标入组 30 人开始时间: 2019年7月26日最近更新: 2023年3月13日

试验速览

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•.Patients aged 18 years and above with WHO-defined MDS or mixed myeloproliferative/myelodysplastic neoplasm overlap syndromes (MPN/MDS)
•.Transfusion dependent: at least two transfusion episodes and at least four units of RBCs, in total during the 16 weeks prior to study entry
•.Life expectancy 6 months or greater
•.Continuing RBC transfusion requirement expected for at least 6 months
•.No new treatments likely to affect transfusion requirements during the study period
•.Able to complete quality of life and community integration questionnaires (CIQ)
•.Able to complete tests of physical function (6-minute walk test, hand-grip strength, use of accelerometer).
•.Red cell phenotyping and/or genotyping results available and reasonable certainty that matched RBCs can be provided for the duration of the study
•.For the qualitative study, able to converse in conversational English for the purposes of the interviews

•.Currently receiving RBC transfusion at an interval of less than or equal to 7 days
•.Unable to tolerate a weekly transfusion schedule, as determined by the treating clinician
•.Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG greater than or equal to 3)
•.Patients on erythropoietic-stimulating agent (ESA) or disease-modifying agents for their MDS (such as lenalidomide, azacitidine, hydroxycarbamide, experimental agents)
•.Patients with myelofibrosis
•.Patients presenting with active bleeding or evidence of significant haemolysis
•.Splenomegaly greater than 5cm below the costal margin
•.Patients with greater than 2 known RBC alloantibodies and/or patients with rare blood groups or RBC antigen types which complicate cross-matching

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