P1580: administration of hypoxic red blood cells to five patients with transfusion-dependent hematological malignancies at haukeland university hospital, norway

Topic: 31. Transfusion medicine Background: Anemia is a common symptom of hematological malignancies, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), due to a reduction in the volume of functional red blood cells (RBCs) in the bone marrow. RBC transfusion is the primary supportive treatment, but this can be associated with adverse events (AEs), and often leads to transfusion dependence. Hypoxic processing and storage of RBCs may benefit those who require frequent transfusions by increasing the interval between transfusions and reducing the release of free iron into circulation and iron overload. Hemanext Inc. (Lexington, MA, United States) has developed a CE mark certified device to process and store RBCs hypoxically – CPD/PAGGSM leukocytes-reduced (LR), O2/CO2 reduced – which may potentially reduce transfusion burden in transfusion-dependent patients and attenuate the oxidative stress associated with acute major bleeding. Aims: To assess the safety of single administration of hypoxic RBCs in transfusion-dependent patients with hematological malignancies at a single center in Norway. Methods: Patients aged ≥18 years with hemoglobin (Hb) ≤9 g/dL and requiring ≥2 units of RBCs in a single transfusion event received hypoxic RBCs as part of an observational pilot safety study. The full study protocol will include 10 patients with hematological malignancies and 10 patients with burns; this scheduled interim safety analysis reports on the first five patients in the hematological malignancy cohort to receive hypoxic RBCs. All patients received one 2-hour transfusion episode of two units of hypoxic RBCs produced using the CPD/PAGGSM LR, O2/CO2 reduced system instead of their usual transfusion of conventionally stored RBCs. The primary objective was the number of AEs up to 24 hours following transfusion initiation and up to 7 days (±1 day) post-transfusion. Secondary objectives included assessment of AEs up to the subsequent transfusion episode or 28 days (±1 day) post-transfusion, whichever occurred first. Additionally, changes in Hb levels post-transfusion were assessed. Results: At this interim analysis, three patients were diagnosed with MDS, one with myelofibrosis and one with AML (80% male, mean [±SD] age 69.8 [±19.3] years; mean [±SD] BMI 24.8 [±3.4] kg/m2). Patients had been receiving conventional RBC transfusions every two weeks prior to study initiation, and all patients received the hypoxic RBCs without complication. Individual patient characteristics are shown in the Table. One AE (rhinovirus) was reported two days post-transfusion. This was deemed mild in severity and unrelated to treatment. No further AEs were reported up to 28 days. Hb levels increased by 17% following the administration of hypoxic RBCs from a pre-transfusion mean (±SD) of 7.7 (±0.5) g/dL to 9.0 (±0.9) g/dL post-transfusion. Summary/Conclusion: This interim analysis showed that transfusion with hypoxic RBCs processed with the CPD/PAGGSM LR, O2/CO2 reduced system was well tolerated in patients with hematological malignancies. Additionally, Hb levels were within the target range at follow-up, suggesting that hypoxically stored RBCs function appropriately. The overall clinical program will assess the benefit to transfusion interval with hypoxic RBCs versus conventional RBCs in patients requiring acute and chronic transfusion.Keywords: Blood transfusion, Myeloid malignancies, Hematological malignancy