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Clinical Trials/NCT06685848
NCT06685848Active, not recruitingNot Applicable

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

Hemanext2 sites in 2 countries24 target enrollmentStarted: November 29, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Hemanext
Enrollment
24
Locations
2
Primary Endpoint
Number of RBCs units per unit of time
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 and marketing authorization through the FDA De Novo process in September 2023.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A - Hemanext ONE system

Experimental

Hypoxic RBCs

Intervention: Hemanext ONE system (Device)

B - Conventional RBCs

Active Comparator

Conventional RBCs

Intervention: Conventional RBCs (Device)

Outcomes

Primary Outcomes

Number of RBCs units per unit of time

Time Frame: Through study completion, an average of 15 months

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.

Secondary Outcomes

  • 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))
  • Mean change in serum ferritin(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.(Through study completion, an average of 15 months)

Investigators

Sponsor
Hemanext
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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