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

NCT06685848 | Recruiting FDA Device

• 1 other identifier: PRO-CLIN-0015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Neoplasms

Keywords

Transfusion; Red Blood Cells; Hypoxic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Volume of blood transfused

  Through study completion, an average of 15 months

• Number of transfusion events

  Through study completion, an average of 15 months

• Mean change in key laboratory assessments (hemoglobin)

  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)

  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 QoL

  At the end of first transfusion cycle at 6 months and at study exit (at 15 months)

Study Arms (2)

A - Hemanext ONE system

EXPERIMENTAL

Hypoxic RBCs

Device: Hemanext ONE system

B - Conventional RBCs

ACTIVE COMPARATOR

Conventional RBCs

Device: Conventional RBCs

Interventions

Hemanext ONE system DEVICE

Hypoxic red blood cells

A - Hemanext ONE system

Conventional RBCs DEVICE

Conventional manufactured Red blood cells

B - Conventional RBCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hemanext: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Håkon Reikvam, PhD, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Badgasarian

CONTACT

(781) 301-7474; jill.bagdasarian@hemanext.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 13, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)