Malignant Haematological Tumour, Primary or Secondary Prophylactic Treatment, Solid Tumour
Conditions
Keywords
cytotoxic chemotherapy, G-CSF, Solid tumour, Malignant haematological tumour
Brief summary
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
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).
Interventions
None listed
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hospitalisation due to febrile neutropenia and/or infection | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment with Nivestim™ as part of daily routine | 6 months | * 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. |
| Description of the efficacy of treatment with Nivestim™ | 6 months | 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 |
| Characterisation of patients being treated with Nivestim™ | 6 months | 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™ |
| Description of the characteristics of the participating physicians | During the study initiation visit | Socio-demographic data (age, gender, field of specialisation, structure of practice, title) |
| Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor) | During the study initiation visit | Criteria for selecting Nivestim™ |
| Detailed description of tolerability and safety | 6 months | * Hospitalisation * Adverse events |
Countries
Germany
Outcome results
None listed