Chemotherapy-induced Febrile Neutropenia (FN), Malignant Hemopathy, Solid Tumors
Conditions
Brief summary
The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
Interventions
BIOLOGICALNivestim®
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients presenting with a solid tumor or a malignant hemopathy, * Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle), * Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias
Exclusion criteria
* Patients presenting with a chronic myeloproliferative syndrome, * Patients presenting with a myelodysplastic syndrome, * Patients showing hypersensitivity to any of the ingredients of Nivestim®, * Patients not receiving chemotherapy, * Patients who were already included in the study during a previous chemotherapy line
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy. | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months | The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment with Nivestim® | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months | Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction) |
| Characteristics of the patients treated with Nivestim® in real-life practice | At Visit 1 | Describe the characteristics of the patients treated with Nivestim® in real-life practice, |
| Methods of treatment with Nivestim® | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months | Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice. |
| Profiles of the physicians participating in the study | At visit 1 | Describe the profiles of the physicians participating in the study |
| General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF) | At visit 1 | Assess the general practice of these physicians with regard to prescription of G-CSF |
Countries
France
Outcome results
None listed