None listed
Conditions
Brief summary
This study aims to assess the feasibility of a low dose, weekly red blood cell (RBC) transfusion for haemoglobin stability in patients with Myelodysplastic syndromes (MDS). Who is it for? You may be eligible for this study if you are an adult with MDS or mixed myeloproliferative/myelodysplastic neoplasm overlap syndrome (MPN/MDS) and who is transfusion dependent (at least two transfusion episodes and at least four units of RBC, in the last 16 weeks) Study details All eligible participants will be randomly allocated to either the usual care Arm A, (continue with their standard treatment) or to the Intervention group, Arm B. The Arm B intervention will involve weekly RBC transfusion using phenotype/genotype matched red blood cells. The number of units per week will be individualised for each patient in the intervention group. All participants involved will experience both treatment arms during the study. Participants will attend weekly transfusions for 6 weeks .The assessment will involve quality of life questionnaires and blood tests. It is possible that maintaining a more stable haemoglobin between transfusions, by transfusing a smaller number of RBCs weekly, may improve quality of life of participants and reduce symptoms. REDDS2 is a collaborative study with the UK National Health Service Blood and Transplant (UK NHSBT) and will inform the design and conduct of a larger trial that will compare red cell transfusion strategies in patients with transfusion-dependent MDS.
Interventions
Weekly red blood cell transfusion using matched red blood cells, for a total of 6 weeks.
Duration of each transfusion will be as per local institutional practice.
Due to the n-of-1 study design, the number of units per week will be individualised for each participant, based on averaging their pre-trial transfusion requirements. This will be determined for each patient individually and approved by their treating clinician and the study PI, prior to randomisation.
There will not be a wash-out p
Weekly red blood cell transfusion using matched red blood cells, for a total of 6 weeks. Duration of each transfusion will be as per local institutional practice. Due to the n-of-1 study design, the number of units per week will be individualised for each participant, based on averaging their pre-trial transfusion requirements. This will be determined for each patient individually and approved by their treating clinician and the study PI, prior to randomisation. There will not be a wash-out period between treatments, as these patients are transfusion dependent hence there cannot be a no-transfusion period. The transfusion will be administered by the research nurse or physician.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
.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
Exclusion criteria
.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
Outcome results
None listed