NCT06685848 Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
| NCT ID | NCT06685848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hemanext |
| Condition | Hematologic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-11-29 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-11-29 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Håkon Reikvam, PhD, MD
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT06685848 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06685848 currently recruiting?
Yes, NCT06685848 is actively recruiting participants. Contact the research team at jill.bagdasarian@hemanext.com for enrollment information.
Where is the NCT06685848 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT06685848 clinical trial?
NCT06685848 is sponsored by Hemanext. The principal investigator is Håkon Reikvam, PhD, MD at Haukeland University Hospital. The trial plans to enroll 24 participants.