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RecruitingLast updated: 27 November 2025

REDDS2: Weekly, low dose red blood cell transfusions to improve haemoglobin stability in people with myelodysplastic syndromes (MDS)A randomised feasibility n-of-1 trial of weekly-interval red cell transfusion myelodysplastic syndromes

Trial purpose

Medical clipboardCancer treatment; Side effect and wellbeing

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

REDDS2

Clinical summary

Summary

This study is looking at whether giving smaller amounts (low dose) of red blod cells (RBC) more often (weekly) can keep haemoglobin levels more stable for people with myelodysplastic syndromes (MDS). This might improve symptoms and quality of life.

You may be eligible for this study if:

  • you are an adult with MDS or mixed myeloproliferative/myelodysplastic neoplasm overlap syndrome (MPN/MDS), and
  • you need regular blood transfusions (at least 2 transfusions and 4 units of RBC in the past 16 weeks).

Study details
All eligible participants will be randomly allocated (by chance) to one of two treatment arms:

  • the usual care Arm A (continue with their standard treatment)
  • 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 blood cell transfusion strategies in people with transfusino-dependent MDS.

 

Conditions

This trial is treating people with myelodysplastic syndromes who are transfusion dependent

Eligibility

Inclusion

.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

.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

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Monash University

Scientific Title

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

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