RecruitingNot ApplicableNCT06685848

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

Multi-Center, Randomized, Controlled Cross-Over Study to Evaluate Safety and Effectiveness of Hypoxic RBCs Processed With the Hemanext ONE System vs Conventional RBCs in Patients With Transfusion-Dependent Haematological Malignancies

Sponsor

Hemanext

Enrollment

24 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

Hematologic Neoplasms

Summary

The overall objective of this study is to collect preliminary effectiveness and safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria13

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