DRKS00017218
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- febrile neutropenia
- Sponsor
- ACCORD Healthcare GmbH
- Enrollment
- 1665
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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