on-Interventional study on treatment with Lipegfilgrastim (Lonquex) in patients with gynecological malignant entities, being treated with myelotoxic chemotherapies.

Recruiting

• Conditions: C50; C56; Malignant neoplasm of breast; Malignant neoplasm of ovary

• Registration Number: DRKS00008901
• Lead Sponsor: Fa. Teva GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Patiens receiving antineoplastic therapy who will be treated during the current chemotherapy line with lipegfilgrastim (Lonquex) (for reduction in the duration of neutropenia or the incidence of febrile neutropenia)
- Adult male and female patients (at least 18 years with no upper age limit)
- Written informed consent to data collection and pseudonymised data

Exclusion Criteria

- Missing patient's informed consent
- Treatment with another G-CSF formulation during the current line of chemotherapy
- Pregnant or breast-feeding women
- Planned myelosuppressive or myeloablative therapy with stem cell support
- Existing or newly diagnosed myelodysplastic syndrome (MDS)
- Known or newly diagnosed chronic myeloid (CML) or acute yeloid leukemia (AML)
- Known severe chronic neutropenia, congenital neutropenia or idiopathic or cyclic neutropenia
- Known HIV infection

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Frequency of cycle delays and dose reductions<br>(observation at a maximum of 6 succeeding chemotherapeutic cycles)

Secondary Outcome Measures

Name	Time	Method
• severe neutropenia [NCI CTCAE grade 3 and 4, febrile neutropenia<br>(FN)] after CTx<br>• therapy with antibiotics-/ antimycotics<br>• time of injection of lipegfilgrastim (Lonquex®) per CTx cycle<br>• patient’s individual risk to develop febrile neutropenia<br>• Leukocyte counts and absolute neutrophil counts (ANC) ahead of first<br>application of CTx<br>• Leukocyte counts and absolute neutrophil counts (ANC) measured<br>within one week after application of CTx<br>• percentage of patients who self inject lipegfilgrastim (Lonquex®)<br>• treating physician’s opinion on overall assessment of efficacy