neutropenia (chemotherapy-induced) D70
Conditions
Interventions
Group 1: 6 mg lipefilgrastim s.c. per chemotherapy cycle
Observation period: Maximum 6 months
Sponsors
TEVA GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients receiving antineoplastic therapy who will be treated for the first time with lipefilgrastim (XM22) for prevention or therapy of chemotherapy-induced neutropenia in the current treatment cycle 2. Adult male and female patients (at least 18 years with no upper age limit) 3. Written informed consent to collecting and pseudonymized data transmission.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with lipefilgrastim (XM22) 2. Missing patient’s informed consent 3. Treatment with another G-CSF formulation during the current line of chemotherapy 4. Pregnant or breast-feeding women 5. Planned myelosuppressive or myeloablative therapy with stem cell support 6. Existing or newly diagnosed myelodysplastic syndrome (MDS), chronic myeloid (CML) or acute myeloid leukemia (AML) 7. Known severe chronic neutropenia, congenital neutropenia or idiopathic or cycle neutropenia 8. Known HIV positivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy profile of lipefilgrastim (XM22) for prophylaxis and/or therapy of chemotherapy-induced neutropenia during routine use. (Time frame: Maximum 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the efficacy of lipefilgrastim (XM22) (Time frame: Maximum 6 months) • To assess the time of injection of lipefilgrastim (XM22) per chemotherapy cycle (Time frame: Maximum 6 months) • To assess the incidence of febrile neutropenia (FN), neutropenia and resulting complications (Time frame: Maximum 6 months) • To assess the patient individual risk to develop febrile neutropenia (Time frame: Maximum 6 months) • To evaluate the use of antibiotics and/or antiomycotics (prophylactic and/or therapeutic) (Time frame: Maximum 6 months) • To evaluate leukocyte counts and absolute neutrophil counts (ANC) as measured in daily clinical practice (Time frame: Maximum 6 months) • To evaluate the patients experience with lipefilgrastim (XM22) injection (Time frame: Maximum 6 months) • To evaluate the treating physician’s opinion on efficacy and safety of lipefilgrastim (XM22) (Time frame: Maximum 6 months) | — |
Countries
Germany
Contacts
Public ContactMatthias Zaiss
Praxis für interdisziplinäre Onkologie & Hämatologie GbR
Outcome results
None listed