Clinical trial NCT02956967: Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Official title: Home Administration Of Nivestim(tm) In The Primary Prophylaxis Of Chemotherapy- Induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home Short Name: Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Interventional Study
Keywords: Non-Interventional Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-11-06
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing cytotoxic chemotherapy treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN.

Brief summary: Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years
* Declaration of informed consent signed by patient
* Patients with a solid tumour or with a malignant haematological tumour
* Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle
* GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment
* Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN

Exclusion Criteria:

* Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)
* Patients who are hypersensitive to one of the excipients of NivestimTM
* Patients not undergoing chemotherapy
* Patients being treated curatively or as secondary prophylaxis with G-CSF

Primary outcomes:
measure: Percentage of Participants With Any Significant Comorbidities
timeFrame: Baseline (Day 1)
measure: Percentage of Participants With Different Types of Haematological Malignancies
timeFrame: Baseline (Day 1)
measure: Percentage of Participants With Different Types of Solid Tumour
timeFrame: Baseline (Day 1)
measure: Duration of Solid Tumour in Participants Prior to Enrolment in Study
timeFrame: Baseline (Day 1)
measure: Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
timeFrame: Baseline (Day 1)
measure: Duration of Different Types of Chemotherapies Received by Participants During Study
timeFrame: Baseline up to 6 months
measure: Percentage of Participants With Response to Study Treatment
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Participants' Overall Satisfaction Scores in Response to the Study Treatment
timeFrame: Baseline up to 6 months
measure: Participant's Assessment for Nivestim Packaging
timeFrame: Baseline up to 6 months
measure: Participant's Assessment of Injection Site Pain and Tolerability
timeFrame: Baseline up to 6 months
measure: Participant's Assessment of Overall Tolerability of Subcutaneous Injection
timeFrame: Baseline up to 6 months
measure: Percentage of Participants With Neutropenia
timeFrame: Baseline up to 6 months
measure: Percentage of Participants With at Least One Infection and Serious Infection
timeFrame: Baseline up to 6 months
measure: Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
timeFrame: Baseline, Cycle 1, 2, 3, 4, 5, 6
measure: Minimum Value of Absolute Neutrophil Count
timeFrame: Cycle 1, 2, 3, 4, 5, 6
measure: Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
timeFrame: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)
measure: Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
timeFrame: Cycle 1, 2, 3, 4, 5, 6
measure: Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
timeFrame: Cycle 1, 2, 3, 4, 5, 6
measure: Percentage of Participants With Febrile Neutropenia
timeFrame: Baseline up to 6 months
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 6 months
Locations:
city: Aschaffenburg
country: Germany
facility: Office of Manfred Welslau
city: Aschaffenburg
country: Germany
facility: Office of Martine Klausmann
city: Augsburg
country: Germany
facility: Office of Bernhard Heinrich
city: Berlin
country: Germany
facility: Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie
city: Berlin
country: Germany
facility: Office of Reinhard Musch
city: Berlin
country: Germany
facility: Office of Peter Klare
city: Bochum
country: Germany
facility: Office of Ute Bückner
city: Chemnitz
country: Germany
facility: Office of Peter Jungberg
city: Gelsenkirchen
country: Germany
facility: Office of Ivo Azeh
city: Hannover
country: Germany
facility: Office of Peter von Wussow
city: Heidenheim
country: Germany
facility: Office of Volker Petersen
city: Herne
country: Germany
facility: Office of Lars-Jörgen Hahn
city: Krefeld
country: Germany
facility: Office of Michael Neise
city: Krefeld
country: Germany
facility: Office of Gunther Rogmans
city: Kronach
country: Germany
facility: Office of Peter Anhut
city: Leipzig
country: Germany
facility: Office of Albrecht Kretzschmar
city: Leipzig
country: Germany
facility: Office of Nidal Gazawi
city: Mannheim
country: Germany
facility: Office of Udo Hieber
city: München
country: Germany
facility: Office of Christoph Salat
city: Münster
country: Germany
facility: Office of Christian Lerchenmüller
city: Oldenburg
country: Germany
facility: Office of Burkhard Otremba
city: Osnabrück
country: Germany
facility: Office of Julian Topaly
city: Rodgau
country: Germany
facility: Office of Andre-Robert Rotmann
city: Scheibenberg
country: Germany
facility: Office of Rene Schubert
city: Stolberg
country: Germany
facility: Office of Matthias Groschek
city: Stralsund
country: Germany
facility: Office of Carsten Hielscher
city: Stuttgart
country: Germany
facility: Office of Thomas Kuhn
city: Wiesbaden
country: Germany
facility: Office of Ortwin Klein
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Otremba B, Hielscher C, Petersen V, Petrik C. Home administration of filgrastim (Nivestim) in primary prophylaxis of chemotherapy-induced febrile neutropenia. Patient Prefer Adherence. 2018 Oct 16;12:2179-2186. doi: 10.2147/PPA.S168029. eCollection 2018.