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

• Conditions: febrile neutropenia; D70.0

• Registration Number: DRKS00017218
• Lead Sponsor: ACCORD Healthcare GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Study Completion: 2023-07-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1665

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The aim is to examine the frequency of occurrence of febrile neutropenia under primary prophylaxis with pegfilgrastim (Pelgraz®) considering the day of Pelgraz® Administration.