febrile neutropenia D70.0
Conditions
Interventions
Group 1: Patients (=18 years) with haematological malignancies or solid tumors (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome) and with an overall risk for febrile ne
Sponsors
ACCORD Healthcare GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to examine the frequency of occurrence of febrile neutropenia under primary prophylaxis with pegfilgrastim (Pelgraz®) considering the day of Pelgraz® Administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the percentage of patients developing a febrile neutropenia and / or where the dose of chemo therapy of the next cycle is reduced or the next therapy cycle is postponed, considering the day of Pelgraz® administration. Determination of the frequency of febrile neutropenia under secondary prophylaxis with pegfilgrastim (Pelgraz®) considering the day of Pelgraz® administration. To investigate differences between patient populations prescribed the Pelgraz® prefilled syringe or Pelgraz® prefilled injector. Investigation of differences between sites that mainly prescribe the Pelgraz® prefilled syringe or the Pelgraz® prefilled injector. Investigation of differences in the application pattern (especially injection day after chemotherapy) between Pelgraz® prefilled syringe and Pelgraz® prefilled injector. Investigation of differences in the occurrence of clinical endpoints (in particular frequency of febrile neutropenia, quality of life) between populations treated with the Pelgraz® prefilled syringe and the Pelgraz® prefilled injector and investigation of correlations with differences in the application pattern of the two Pelgraz® dosage forms. To assess the evaluation of patients who use the Pelgraz® pre-filled injector themselves. Determination of the percentage of patients receiving p.o / i.v. anti-infective agents and / or being hospitalized due to febrile neutropenia or infections, considering the day of Pelgraz® administration. Determination of the frequency of switches from another G-CSF to Pelgraz® and the reasons therefore. Validity of predictive factors for febrile neutropenia (with hospitalization) or infections (with hospitalization) under G-CSF prophylaxis based on the following criteria: o Chemotherapy (dose-dense versus not-dose-dense with a cycle of more than 14 days) o Patients with the following risk factors: • Age > 65 years • Advanced cancer • Previous febrile neutropenia • Female • Reduced general condition ( | — |
Countries
Germany
Contacts
Public ContactRainer Apfel
ACCORD Healthcare GmbH
Outcome results
None listed