on-interventional study on treAtment of chemotherapy-inDuced neutropenia with LIpefilgRastim (XM22)

Recruiting

• Conditions: neutropenia (chemotherapy-induced); D70; Agranulocytosis

• Registration Number: DRKS00005711
• Lead Sponsor: TEVA GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy profile of lipefilgrastim (XM22) for prophylaxis and/or therapy of chemotherapy-induced neutropenia during routine use. <br>(Time frame: Maximum 6 months)

Secondary Outcome Measures

Name	Time	Method
• To evaluate the efficacy of lipefilgrastim (XM22) (Time frame: Maximum 6 months)<br><br>• To assess the time of injection of lipefilgrastim (XM22) per chemotherapy cycle <br>(Time frame: Maximum 6 months)<br><br>• To assess the incidence of febrile neutropenia (FN), neutropenia and resulting complications (Time frame: Maximum 6 months)<br><br>• To assess the patient individual risk to develop febrile neutropenia <br>(Time frame: Maximum 6 months)<br><br>• To evaluate the use of antibiotics and/or antiomycotics (prophylactic and/or therapeutic) (Time frame: Maximum 6 months)<br><br>• To evaluate leukocyte counts and absolute neutrophil counts (ANC) as measured in daily clinical practice (Time frame: Maximum 6 months)<br><br>• To evaluate the patients experience with lipefilgrastim (XM22) injection (Time frame: Maximum 6 months)<br><br>• To evaluate the treating physician’s opinion on efficacy and safety of lipefilgrastim (XM22) <br>(Time frame: Maximum 6 months)