Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion

Inclusion Criteria:

* Male or female aged 18 or older
* Patients with a documented diagnosis of a haematological malignancy requiring chronic transfusions.
* If MDS patient, Have low risk or intermediate risk MDS per either IPSS-R (https://www.mds-foundation.org/ipss-r-calculator/) or IPSS-M (IPSS-M Risk Calculator (mds-risk-model.com))
* If MDS patient, a bone marrow aspirate completed within the 6 months prior to study enrolment, and which did not show progression to higher risk MDS
* Have RBC transfusion dependence (at least 2 RBC units /8 weeks during the last 16 weeks)
* Baseline RBC transfusion threshold of ≤ 9 g/dL
* ECOG (Eastern Cooperative Oncology Group) performance status \< 3
* Have signed the informed consent form and are willing to comply with the study visits and procedures
* If on Iron Chelation Therapy, have been on a stable dose for ≥3 months prior to screening

Exclusion Criteria:

* Have a life expectancy of less than 1 year
* Have palpable splenomegaly (more than 3 cm below the mid clavicular line)
* Have other associated causes of anemia (including auto-immune hemolysis or active hemorrhage, or progression to acute leukemia)
* If prescribed erythropoiesis affecting disease modifying agents (e.g. G-CSF, erythropoietin), have not been on a stable dose for 90 days
* Is currently taking Luspatercept or other investigational erythropoiesis affecting disease modifying agent
* Have severe renal insufficiency with creatinine clearance (MDRD or CKD EPI) below 30ml/min
* Have lung disease with hypoxia or oxygen-dependent
* Have severe coronary artery disease (including unstable angina or recent myocardial infraction) or severe heart failure (left ventricular ejection fraction less than 30%)
* Have a history of cancer active in the previous 3 years, except local cervix cancer, or basal cell cutaneous carcinoma
* Have a history of allo-immunization other than rhesus Kell that cannot be managed by the local blood bank
* Are a female of child-bearing potential that is pregnant, planning to become pregnant in the next 14 months or breastfeeding
* Are a patient under guardianship or curatorship
* Are currently participating in another interventional study evaluating an erythropoiesis affecting disease modifying agent