Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

• ClinicalTrials.gov Identifier: NCT02956967
• Recruitment Status: Completed
• First Posted: November 6, 2016
• Results First Posted: February 11, 2019
• Last Update Posted: February 11, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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

Condition or disease	Intervention/treatment
Non-Interventional Study	Other: Overall satisfaction questionnaires of home use of Nivestim

Study Design

• Study Type: Observational
• Actual Enrollment: 171 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: September 23, 2015
• Actual Primary Completion Date: December 12, 2016
• Actual Study Completion Date: December 12, 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patients receiving Nivestim	Other: Overall satisfaction questionnaires of home use of Nivestim

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Any Significant Comorbidities [ Time Frame: Baseline (Day 1) ]
   Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.
2. Percentage of Participants With Different Types of Haematological Malignancies [ Time Frame: Baseline (Day 1) ]
   Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.
3. Percentage of Participants With Different Types of Solid Tumour [ Time Frame: Baseline (Day 1) ]
   Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.
4. Duration of Solid Tumour in Participants Prior to Enrolment in Study [ Time Frame: Baseline (Day 1) ]
   Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.
5. Number of Participants Who Received Chemotherapy Prior to Enrolment in Study [ Time Frame: Baseline (Day 1) ]
6. Duration of Different Types of Chemotherapies Received by Participants During Study [ Time Frame: Baseline up to 6 months ]
7. Percentage of Participants With Response to Study Treatment [ Time Frame: Baseline up to 6 months ]

Secondary Outcome Measures :

1. Participants' Overall Satisfaction Scores in Response to the Study Treatment [ Time Frame: Baseline up to 6 months ]
   Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.
2. Participant's Assessment for Nivestim Packaging [ Time Frame: Baseline up to 6 months ]
   Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
3. Participant's Assessment of Injection Site Pain and Tolerability [ Time Frame: Baseline up to 6 months ]
   Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.
4. Participant's Assessment of Overall Tolerability of Subcutaneous Injection [ Time Frame: Baseline up to 6 months ]
   Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
5. Percentage of Participants With Neutropenia [ Time Frame: Baseline up to 6 months ]
   Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure.
6. Percentage of Participants With at Least One Infection and Serious Infection [ Time Frame: Baseline up to 6 months ]
   Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
7. Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 [ Time Frame: Baseline, Cycle 1, 2, 3, 4, 5, 6 ]
8. Minimum Value of Absolute Neutrophil Count [ Time Frame: Cycle 1, 2, 3, 4, 5, 6 ]
9. Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle [ Time Frame: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6) ]
10. Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count [ Time Frame: Cycle 1, 2, 3, 4, 5, 6 ]
11. Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count [ Time Frame: Cycle 1, 2, 3, 4, 5, 6 ]
12. Percentage of Participants With Febrile Neutropenia [ Time Frame: Baseline up to 6 months ]
    Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and absolute neutrophil count of less than (<) 1.0 × 10^9 Neutrophils per Liter.

Other Outcome Measures:

1. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 6 months ]
   An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

Germany

Office of Manfred Welslau

Aschaffenburg, Germany, 63739

Office of Martine Klausmann

Aschaffenburg, Germany, 63739

Office of Bernhard Heinrich

Augsburg, Germany, 86150

Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie

Berlin, Germany, 10117

Office of Reinhard Musch

Berlin, Germany, 13055

Office of Peter Klare

Berlin, Germany, 13595

Office of Ute Bückner

Bochum, Germany, 44787

Office of Peter Jungberg

Chemnitz, Germany, 09117

Office of Ivo Azeh

Gelsenkirchen, Germany, 45879

Office of Peter von Wussow

Hannover, Germany, 30449

Office of Volker Petersen

Heidenheim, Germany, 89518

Office of Lars-Jörgen Hahn

Herne, Germany, 44623

Office of Michael Neise

Krefeld, Germany, 47804

Office of Gunther Rogmans

Krefeld, Germany, 47805

Office of Peter Anhut

Kronach, Germany, 96317

Office of Albrecht Kretzschmar

Leipzig, Germany, 04103

Office of Nidal Gazawi

Leipzig, Germany, 04107

Office of Udo Hieber

Mannheim, Germany, 68165

Office of Christoph Salat

München, Germany, 80638

Office of Christian Lerchenmüller

Münster, Germany, 48149

Office of Burkhard Otremba

Oldenburg, Germany, 26121

Office of Julian Topaly

Osnabrück, Germany, 49076

Office of Andre-Robert Rotmann

Rodgau, Germany, 63110

Office of Rene Schubert

Scheibenberg, Germany, 09481

Office of Matthias Groschek

Stolberg, Germany, 52222

Office of Carsten Hielscher

Stralsund, Germany, 18435

Office of Thomas Kuhn

Stuttgart, Germany, 70193

Office of Ortwin Klein

Wiesbaden, Germany, 65191

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02956967
• Other Study ID Numbers: ZOB-NIV-1504; C1121004 ( Other Identifier: Alias Study Number )
• First Posted: November 6, 2016
• Results First Posted: February 11, 2019
• Last Update Posted: February 11, 2019
• Last Verified: September 2018

Keywords provided by Pfizer:

Non-Interventional Study

Additional relevant MeSH terms:

Neutropenia; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia; Agranulocytosis; Leukopenia; Leukocyte Disorders; Hematologic Diseases