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

Official title

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

Overview

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.

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

Interventions

• Device Hemanext ONE system
  Hypoxic red blood cells
• Device Conventional RBCs
  Conventional manufactured Red blood cells

Primary outcome measures

• Number of RBCs units per unit of time [Time frame: Through study completion, an average of 15 months]

Secondary outcome measures (7)

• Volume of blood transfused [Time frame: Through study completion, an average of 15 months]
• Number of transfusion events [Time frame: Through study completion, an average of 15 months]
• Mean change in key laboratory assessments (hemoglobin) [Time frame: 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) [Time frame: 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 [Time frame: At the end of first transfusion cycle at 6 months and at study exit (at 15 months)]
• Mean change in serum ferritin [Time frame: 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. [Time frame: Through study completion, an average of 15 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Norway · 1 center

• Haukeland University Hospital — Bergen

Identifiers

NCT: NCT06685848 · PRO-CLIN-0015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗