REDDS

Trial Overview

Red blood cell transfusion thresholds and QoL in myelodysplastic syndromes: a pilot, feasibility study

Inclusion criteria

1. All patients with MDS 18 years of age and with < 20% blasts on bone marrow aspirate (WHO classification), including non-proliferative CMML and other MDS/MPN overlap diseases. These patients will include both those recently diagnosed and with an established diagnosis

2. Transfusion dependent: at least 1 red cell transfusion episode per month in the last 8 weeks

3. Life expectancy > 6 months

Exclusion criteria

1. Unable, in the opinion of the attending clinician, to tolerate restrictive or liberal red cell transfusion thresholds (e.g. clinically significant cardio-respiratory compromise)

2. Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG 3)

3. Patients being actively treated with erythropoiesis stimulating agents (ESAs) or disease modifying agents for their MDS (such as lenalidomide, azacitidine, hydroxycarbamide, experimental agents), as these may exert their own effects on the patients quality of life and may render patients transfusion independent

4. Patients with idiopathic myelofibrosis

5. Patients in whom the attending clinician considers that active bleeding or on-going haemolysis contribute significantly to the cause of anaemia.

6. Patients presenting with splenomegaly > 5cm below the costal margin

Research Nurse

Stewart McConnell

Tel: 01132068577

E-mail: [email protected]

Other trials currently active for Myelodysplastic Syndromes

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MDS-Bio1

Molecular and functional characterisation of bone marrow function in normal subjects, myelodysplastic syndromes (MDS) and secondary disorders of haematopoiesis