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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Device: Hemanext ONE system; Device: Conventional RBCs

Detailed Description

The primary objective is to evaluate whether the total number of hypoxically stored red blood cell (RBCs) units per unit of time transfused in patients with haematologic malignancies, requiring chronic blood transfusion therapy, is non-inferior to the total number of units of conventionally stored RBCs per unit of time transfused.

Secondary objectives include the following:

1. Analysis of volume of blood transfused
2. Analysis of number of transfusion events throughout the study period
3. Key laboratory assessments (hemoglobin and hematocrit) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs
4. Evaluation of Quality of Life (QoL)
5. Change in serum ferritin
6. Safety assessment

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Badgasarian; Phone Number: (781) 301-7474; Email: jill.bagdasarian@hemanext.com

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Hakon Reikvam, PhD, MD; Phone Number: +4791 66 70 94; Email: hakon.reikvam@uib.no
    • Principal Investigator: Hakon Reikvam, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - Hemanext ONE system; Hypoxic RBCs	Device: Hemanext ONE system; Hypoxic red blood cells
Active Comparator: B - Conventional RBCs; Conventional RBCs	Device: Conventional RBCs; Conventional manufactured Red blood cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of RBCs units per unit of time	The difference in the total number of hypoxic RBCs units per unit of time transfused to MDS patients during the study period compared to the total number of conventional RBCs units per unit of time transfused.	Through study completion, an average of 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of blood transfused	The mean volume of blood per patient transfused with Hemanext ONE and with standard RBC units will be analyzed and compared	Through study completion, an average of 15 months
Number of transfusion events	Mean number of transfusion events throughout the study period	Through study completion, an average of 15 months
Mean change in QoL	Mean change in QoL as assessed by the EORTC QLQ-C30 (EORTC Quality of Life Questionnaire). Scores from 1-4 (where 1 indicates a better outcome and 4 indicates a worse outcome): Not at all; A little; Quite a bit; Very Much Additionally, a rating from 1-7, where 1 is "Very poor" and 7 is "Excellent"	At the end of first transfusion cycle at 6 months and at study exit (at 15 months)
Mean change in serum ferritin	Mean change from baseline in serum ferritin (assessment during baselines 1 and 2 (first pre-transfusion visit of each arm) to pre-transfusion of first washout visit and pre-transfusion of the final visit).	At the end of first transfusion cycle at 6 months and at study exit (at 15 months)
Safety assessment in terms of frequency of adverse event reactions and device deficiencies.	Safety assessment in terms of frequency of adverse event reactions and device deficiencies.	Through study completion, an average of 15 months
Mean change in key laboratory assessments (hemoglobin)	Mean change in key laboratory assessments (hemoglobin) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.	Up to 15-60 minutes post transfusion, up to day 7, up to pre-transfusion of first washout visit (at 6 months), up to transfusion on the final transfusion visit (at 15 months)
Mean change in key laboratory assessments (hematocrit)	Mean change in key laboratory assessments (hematocrit) after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs.	Up to 15-60 minutes post transfusion, up to day 7, up to pre-transfusion of first washout visit (at 6 months), up to transfusion on the final transfusion visit (at 15 months)

Collaborators and Investigators

• Sponsor: Hemanext
• Investigators: Principal Investigator: Håkon Reikvam, PhD, MD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Red Blood Cells; Transfusion; Hypoxic
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Hypoxia
• Other Study ID Numbers: PRO-CLIN-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes