Clinical trial · Observational
Nivestim™ in Treatment of Malignant Diseases
The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
NCT01627990CI-TRIAL-00018648completedClinicalTrials.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 purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.
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 |
|---|---|---|---|
| Malignant Haematological Tumour | — | UNRESOLVED | — |
| Primary or Secondary Prophylactic Treatment | — | UNRESOLVED | — |
| Solid Tumour | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of hospitalisation due to febrile neutropenia and/or infection
- timeFrame
- 6 months
Secondary outcomes (6)
- measure
- Characterisation of patients being treated with Nivestim™
- timeFrame
- 6 months
- description
- 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™
- measure
- Treatment with Nivestim™ as part of daily routine
- timeFrame
- 6 months
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (2)
- DERIVEDFruehauf S, Otremba B, Stotzer O, Rudolph C. Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study. Adv Ther. 2016 Nov;33(11):1983-2000. doi: 10.1007/s12325-016-0419-1. Epub 2016 Oct 14. PMID 27743353
- 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