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

• Conditions: C61; C67; Malignant neoplasm of prostate; Malignant neoplasm of bladder

• Registration Number: DRKS00008907
• Lead Sponsor: Fa. Teva GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-17
• Study Completion: 2016-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Patients 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 transmission to the performing CRO and the sponsor.

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 leukemia (CML)
- 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
• severe neutropenia [NCI CTCAE grade 3 and 4, febrile neutropenia (FN)] after CTx (observation at a maximum of 6 consecutive chemotherapeutic cycles per patient)

Secondary Outcome Measures

Name	Time	Method
• Frequency of cycle delays and dose reductions<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