CompletedNot Applicable

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

France2,114 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT01574235

SponsorHospira, now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-02

View on ClinicalTrials.gov More Solid Tumors trials