Nivestim™ in Treatment of Malignant Diseases

Hospira, now a wholly owned subsidiary of Pfizer386 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

386

Conditions

Solid Tumour Malignant Haematological Tumour Primary or Secondary Prophylactic Treatment

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (48)

Outcomes

Primary Outcomes

Incidence of hospitalisation due to febrile neutropenia and/or infection

Time frame: 6 months

Secondary Outcomes

Characterisation of patients being treated with Nivestim™

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™

Time frame: 6 months

Treatment with Nivestim™ as part of daily routine

* 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.

Time frame: 6 months

Description of the efficacy of treatment with Nivestim™

Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters: * Duration of neutropenia * Incidence of febrile neutropenia * Frequency of infection * Delay in chemotherapy cycles due to neutropenia * Reduction in chemotherapy doses due to neutropenia * Assessment of patient

Time frame: 6 months

Detailed description of tolerability and safety

* Hospitalisation * Adverse events

Time frame: 6 months

Description of the characteristics of the participating physicians

Socio-demographic data (age, gender, field of specialisation, structure of practice, title)

Time frame: During the study initiation visit

Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Facharzt für Innere Medizin, Onkologie, Hämatologie

Ahaus, Germany

Studienzentrum Hämatologie/Onkologie/Diabetologie

Aschaffenburg, Germany

Facharzt für Innere Medizin Hämatologie / Onkologie

Bad Säckingen, Germany

MediOnko-Institut GbR

Berlin, Germany

Onkoplan GmbH/Onkologische Schwerpunkpraxis

Berlin, Germany

FA f. Frauenheilkunde und Geburtshilfe Gynäkologische Onkologie

Chemnitz, Germany

MVZ Delitzsch GmbH

Delitzsch, Germany

Gesellschaft für onkologische Studien Dortmund mbH

Dortmund, Germany

Gemeinschaftspraxis

Dresden, Germany

Gemeinschaftspraxis Haematologie/Medizin Onkologie

Düsseldorf, Germany

...and 38 more locations