Clinical trial · Observational
Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice
NCT01574235CI-TRIAL-00018684completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Febrile Neutropenia (FN) | — | UNRESOLVED | — |
| Malignant Hemopathy | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivestim® | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Curative or prophylactic Nivestim® treatment for FN
- interventionNames
- Biological: Nivestim®
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 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
- description
- 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 outcomes (5)
- measure
- Efficacy of treatment with Nivestim®
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547. PMID 24237790