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Phase II Study of Prophylactic Non-Irradiated Granulocyte Transfusions in AML Patients Receiving Induction Chemotherapy

Year: 2017
Type: article
Study design: Clinical Trial
Abstract: Background: Patients with Acute Myeloid Leukemia (AML) experience profound neutropenia; infections remain the leading cause of morbidity and mortality.Transfusion of functional non-irradiated allogeneic granulocytes may treat or prevent infections in AML patients, and may also have anti-leukemic benefits. Study Design:Patients free of infection, with a diagnosis of AML or high-risk myelodysplastic syndrome undergoing induction or first-salvage therapy were eligible.Allogeneic Granulocyte Transfusions (GTs) were administered to neutropenic (<0.5 × 10 9 /L) patients every 3-4 days until sustained ANC recovery, initiation of new therapy, or completion of 6 weeks on study.Results: 45 patients enrolled with a median age of 67 years (range 23-83); 27 (60%) were male.Five patients (11%) never received a GT, due to donor screening failure and/or donor unavailability.119 donors donated 156 granulocyte concentrates to the remaining 40 patients.The median number of GTs transfused per patient was 3 (range 1-9).All patients experienced >1 neutropenic fever, with an average of one infectious episode per patient.Other adverse reactions were urticaria/pruritis (n=1), rash (n=1), and hypotension (n=1).Response to leukemiadirected therapy included complete remission in 50%, overall response rate of 70%, and 8-week mortality of 8%.Median overall survival was 15 months, with 51% 1-year survival.Conclusion: Administration of non-irradiated functional allogeneic GTs to neutropenic MDS/AML patients is safe and feasible.No transfusion-associated graft-versus-host-disease (TA-GVHD) was reported and no increased toxicity was described, including among the 10% receiving subsequent allogeneic stem cell transplant.The favorable patient outcomes within this diverse group of primarily elderly AML are notable.
Language: English
Subfield: Oncology
Field: Medicine
Open Access status: hybrid
OpenAlex ID: W2606264358
FWCI: 0.215
Cites: 26
Cited by: 2
Related to: 10