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New treatment option for Hematologic Neoplasms
Official title Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
ClinicalTrials.gov ID: NCT06685848
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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)
You likely can't join 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
See the full eligibility 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
- 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 treatment study evaluating an erythropoiesis affecting disease modifying agent
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.