Nivestim™ in Treatment of Malignant Diseases

Hospira

Status: Completed

Conditions: Malignant Haematological Tumour; Solid Tumour; Primary or Secondary Prophylactic Treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT01627990

VENICE

Details and patient eligibility

About

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.

Full 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).

Enrollment: 386 patients

Sex: All

Volunteers: No Healthy Volunteers

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)