Nivestim™ in Treatment of Malignant Diseases

Study Overview
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Brief Summary
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The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.

Detailed Description
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This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).

Official Title
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The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases

Conditions
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Solid Tumour, Malignant Haematological Tumour, Primary or Secondary Prophylactic Treatment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No age limit Declaration of informed consent signed by patient or legal guardian Patients with a solid tumour or with a malignant haematological tumour Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN). Exclusion Criteria: Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS) Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™ Patients not undergoing chemotherapy Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospitalisation due to febrile neutropenia and/or infection |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of patients being treated with Nivestim™ | Characterisation of patient based on: Socio-demographic data previous medical history (Surgical and therapeutic) Tumour data Chemotherapy data Clinical and laboratory data preceding treatment with Nivestim™ | 6 months | 
| Treatment with Nivestim™ as part of daily routine | Therapeutic indication Dosage and mode of administration Duration of treatment (planned and carried through) Delay in start of treatment since last chemotherapy for purposes of prophylaxis Absolute Neutrophil Count (ANC) during study. | 6 months | 
| Description of the efficacy of treatment with Nivestim™ | Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters: Duration of neutropenia Incidence of febrile neutropenia Frequency of infection Delay in chemotherapy cycles due to neutropenia Reduction in chemotherapy doses due to neutropenia Assessment of patient | 6 months | 
| Detailed description of tolerability and safety | Hospitalisation Adverse events | 6 months | 
| Description of the characteristics of the participating physicians | Socio-demographic data (age, gender, field of specialisation, structure of practice, title) | During the study initiation visit | 
| Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor) | Criteria for selecting Nivestim™ | During the study initiation visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytotoxic chemotherapy, G-CSF, Solid tumour, Malignant haematological tumour