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

Launched by HEMANEXT · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new blood transfusion method using a device called the Hemanext ONE, which creates special red blood cells (RBCs) for patients with blood cancers, known as hematologic neoplasms. The main aim is to gather information on how effective and safe this new method is compared to traditional blood transfusions. The trial is currently looking for participants who are 18 years or older and have a specific type of blood cancer that requires regular blood transfusions.

To be eligible for the study, participants need to have been receiving at least two units of blood every eight weeks in the last four months and have a certain level of hemoglobin (a protein in red blood cells) in their blood. They should also be physically able to participate, meaning they should not have severe health issues that would prevent them from completing the study. If you or someone you know is interested in participating, they can expect to undergo regular check-ups and tests throughout the study to monitor their health and how well the new treatment is working.

Gender

ALL

Eligibility criteria

• 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