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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00008907

Enrollment

300

Registered

2015-09-17

Start date

2015-07-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61 C67

Interventions

Group 1: Observation of the application of Lonquex(R) (Lipegfilgrastim) for a period of 6 months. Collection of data e.g. about demography, patient status (ECOG), primary disease/tumor anamnesis, ther

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
• 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

Measure	Time frame
• Frequency of cycle delays and dose reductions • therapy with antibiotics-/ antimycotics • time of injection of lipegfilgrastim (Lonquex®) per CTx cycle • patient’s individual risk to develop febrile neutropenia • Leukocyte counts and absolute neutrophil counts (ANC) ahead of first application of CTx • Leukocyte counts and absolute neutrophil counts (ANC) measured within one week after application of CTx • percentage of patients who self inject lipegfilgrastim (Lonquex®) • treating physician’s opinion on overall assessment of efficacy	—

Measure

Time frame

• Frequency of cycle delays and dose reductions • therapy with antibiotics-/ antimycotics • time of injection of lipegfilgrastim (Lonquex®) per CTx cycle • patient’s individual risk to develop febrile neutropenia • Leukocyte counts and absolute neutrophil counts (ANC) ahead of first application of CTx • Leukocyte counts and absolute neutrophil counts (ANC) measured within one week after application of CTx • percentage of patients who self inject lipegfilgrastim (Lonquex®) • treating physician’s opinion on overall assessment of efficacy

—

Countries

Germany

Contacts

Public ContactAnne-Katrin Ullner

OnkoDataMed GmbH

anne-katrin.ullner@onkodatamed.de03342 4268910

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026