Special blood storage could cut transfusions for cancer patients
NCT ID NCT06685848
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study tests whether red blood cells stored with less oxygen (hypoxic RBCs) are safer and more effective than standard transfusions for people with blood cancers who need regular blood. About 24 adults with transfusion-dependent blood cancers will receive both types of blood in a random order. The goal is to see if the special cells reduce the number of transfusions needed over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University Health System
Durham, North Carolina, 27705, United States
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Haukeland University Hospital
Bergen, 5021, Norway
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Other studies related to the condition(s) this trial covers.
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