Comparing a new red blood cell transfusion method with standard transfusions
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
This study is testing a new way to store and transfuse red blood cells to see if it works just as well and is safe for patients with blood cancers who need regular transfusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hemanext Industry-sponsored |
| Locations | 1 site (Bergen) |
| Trial ID | NCT06685848 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of hypoxically stored red blood cells (RBCs) using the Hemanext ONE device in patients with hematologic malignancies who require chronic transfusions. The primary goal is to determine if the transfusion of these hypoxic RBCs is non-inferior to conventional RBC transfusions in terms of the total number of units transfused over time. Secondary objectives include analyzing transfusion volume, frequency, laboratory assessments, quality of life, serum ferritin changes, and safety evaluations. The Hemanext ONE device has received CE mark approval, indicating its regulatory compliance for use in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a documented diagnosis of a hematologic malignancy requiring chronic blood transfusions.
Not a fit: Patients with a life expectancy of less than one year or those with higher risk MDS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective transfusion option for patients with hematologic malignancies.
How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in improving transfusion methods for patients with hematologic conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bergen
- Haukeland University Hospital — Bergen, Norway (Recruiting)
Study contacts
- Principal investigator: Håkon Reikvam, PhD, MD — Haukeland University Hospital
- Study coordinator: Jill Badgasarian
- Email: jill.bagdasarian@hemanext.com
- Phone: (781) 301-7474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.