Prospective, non-interventional, open-label study on the prophylactic use of a pegylated filgrastim (Pelgraz®) to reduce the duration of neutropenia and the incidence of febrile neutropenia under conventional chemotherapy for the treatment of haematological malignancies and solid tumors - PROOF

ACCORD Healthcare GmbH0 个研究点目标入组 1,665 人开始时间: 2019年5月29日最近更新: 2024年8月19日

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•Male or female patients =18 years with haematological malignancies or solid tumors who receive a conventional cytotoxic chemotherapy and who are treated prophylactically with Pelgraz® according to the SmPC.
•Risk of febrile neutropenia between = 10% and 20% (with individual risk factors) as assessed by the attending physician or overall FN risk of > 20%.
•Written informed consent given by the patient or by relatives / caregivers for the retro- and prospective collection, transfer and analysis of pseudonymized data as well as for verification of patient data during a monitoring visit.

•Hypersensitivity to pegfilgrastim or to any other ingredient of Pelgraz®
•Patients with severe congenital neutropenia who develop leukemia or who show signs of leukemia
•Patients with myelodysplasia or chronic myelotic leukaemia
•Patients with a recent history of pulmonary infiltrates or pneumonia
•For female patients: pregnancy or breastfeeding

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