Granulocyte Transfusion Therapy in Patients with Neutropenic Fever ("GRANITE")

• Applicant: Professor Dr. Kai Hübel
• Subject Area: Hematology, Oncology
• Term: from 2009 to 2015
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 73789062

Infectious complications in patients with cancer remain a major cause of morbidity and mortality, especially during prolonged neutropenic periods following intensive chemotherapy. Since polymorphonuclear leukocytes play a key role in the first line of host defense against infection, the transfusion of granulocytes should be a logical approach. However, the role of granulocyte transfusion therapy and its timely application has not been defined yet. Currently it is premature to conclude that granulocytes collected from G-CSF-stimulated donors for transfusion purposes can be used successfully to prevent or treat infections in severely neutropenic patients. This is a randomized, multicenter clinical trial to evaluate the efficacy of granulocyte transfusion therapy in neutropenic patients not responding to standard antimicrobial therapy. Overall, a total of 100 infant and adult patients will be enrolled. Randomization will be performed to a group receiving standard care plus granulocyte transfusion therapy or to a group receiving standard care without granulocyte transfusion therapy. The primary hypothesis of the trail is the significant reduction of days of fever in the transfusion cohort by granulocyte transfusions. For mobilization procedures, unrelated donors will be identified by the blood bank.

• DFG Programme: Clinical Trials