Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

Hospira

Status: Completed

Conditions: Malignant Hemopathy; Chemotherapy-induced Febrile Neutropenia (FN); Solid Tumors

Treatments: Biological: Nivestim®

Study type: Observational

Funder types: Industry

Identifiers

NCT01574235

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Details and patient eligibility

About

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.

Enrollment: 2,114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,114 participants in 1 patient group

Curative or prophylactic Nivestim® treatment for FN

Treatment:

Biological: Nivestim®