Chemotherapy-induced Febrile NeutropeniaNCT02178475
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
An observational study of Chemotherapy-induced Febrile Neutropenia, run by Amgen at 74 sites in 9 countries.
Trial summary
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Febrile Neutropenia
- How many people
- 943 participants
- Where
- 74 sitesin 9 countries
- Study dates
- 18 Jul 2014to 28 Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NHL or breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (> 20%) per published studies or international guidelines, and who started pegfilgrastim in Cycle 1
Who may be able to join
- Age ≥ 18 years old.
- Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
- Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
- Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.
Who cannot join
- Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the national competent authorities for any indication.
- Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).
Trial locations and contacts
74 sites in 9 countries.
74 sites in 9 countries
France15 sites
Research Site
Aix-en-Provence, 13100
Research Site
Amiens, 80000
Research Site
Beuvry, 62660
Research Site
Marseille, 13009
Research Site
Marseille, 13385
Research Site
Meaux, 77100
Research Site
Nancy, 54100
Research Site
Nîmes, 30029
Research Site
Orléans, 45067
Research Site
Périgueux, 24004
Research Site
Perpignan, 66000
Research Site
Pierre-Bénite, 69495
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Sarcelles, 95200
Research Site
Strasbourg, 67000
Greece13 sites
Research Site
Athens, 11527
Research Site
Athens, 11528
Research Site
Athens, 12462
Research Site
Chania, 73300
Research Site
Kalamata, 24100
Research Site
Larissa, 41110
Research Site
Nea Kifissia, Athens, 14564
Research Site
Papagou, 11526
Research Site
Piraeus, 18537
Research Site
Thessaloniki, 54622
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 54645
Research Site
Thessaloniki, 55236
Romania12 sites
Research Site
Baia Mare, 430031
Research Site
Brăila, 810325
Research Site
Bucharest, 010825
Research Site
Bucharest, 022328
Research Site
Bucharest, 022338
Research Site
Bucharest, 030171
Research Site
Bucharest, 031864
Research Site
Câmpina, 105600
Research Site
Cluj-Napoca, 400124
Research Site
Iași, 700483
Research Site
Oradea, 410469
Research Site
Ploieşti, 100337
Germany9 sites
Research Site
Bonn, 53111
Research Site
Dresden, 01307
Research Site
Fulda, 36043
Research Site
Hildesheim, 31134
Research Site
Kassel, 34119
Research Site
Stolberg, 52222
Research Site
Troisdorf, 53840
Research Site
Velbert, 42551
Research Site
Westerstede, 26655
Poland9 sites
Research Site
Bialystok, 15-027
Research Site
Gdynia, 81-519
Research Site
Koszalin, 75-581
Research Site
Krakow, 31-501
Research Site
Krakow, 31-531
Research Site
Poznan, 61-485
Research Site
Wałbrzych, 58-309
Research Site
Warsaw, 02-097
Research Site
Warsaw, 02-781
Austria6 sites
Research Site
Eggenburg, 3730
Research Site
Graz, 8036
Research Site
Leoben, 8700
Research Site
Schwarzach im Pongau, 5620
Research Site
Vienna, 1030
Research Site
Vienna, 1090
Czechia6 sites
Research Site
Chomutov, 430 12
Research Site
Hořovice, 268 31
Research Site
Nový Jičín, 741 01
Research Site
Pilsen, 304 60
Research Site
Prague, 100 34
Research Site
Prague, 128 08
About this study
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
- Conditions
- Chemotherapy-induced Febrile Neutropenia
- Keywords
- NHL, Breast Cancer
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Pegfilgrastim | Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Febrile Neutropenia
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary outcomes (16)
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.
Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered).
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Discontinued G-CSF Prophylaxis
Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy).
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.
Data includes both temporary and permanent pegfilgrastim discontinuation.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
Data includes both temporary and permanent discontinuation of G-CSF prophylaxis.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No Pegfilgrastim Prophylaxis
A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With no G-CSF Prophylaxis
A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.
Data includes both temporary and permanent pegfilgrastim discontinuation.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of G-CSF Prophylaxis
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Percentage of Participants Who Experienced Complications of Febrile Neutropenia
Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis
The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred
The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred
The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis
The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.
Measured: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study start18 Jul 2014
- Primary completion28 Oct 2016
- Study completion28 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178475
- Sponsor's protocol ID
- 20120214
- Status last verified
- Oct 2017
- First submitted
- 10 Jun 2014
- Last updated
- 23 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.
PubMed 35426046
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
- ClinicalTrials.gov ID
- NCT02178475
- Acronym / sponsor ID
- 20120214
- Conditions
- Chemotherapy-induced Febrile Neutropenia
- Keywords
- NHL, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Pegfilgrastim | – | –Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NHL or breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (> 20%) per published studies or international guidelines, and who started pegfilgrastim in Cycle 1
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
- Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
- Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.
Key exclusion criteria (2 listed)
- Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the national competent authorities for any indication.
- Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With Febrile Neutropenia
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
16 secondary outcomes
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Discontinued G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No Pegfilgrastim Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With no G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Percentage of Participants Who Experienced Complications of Febrile Neutropenia
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35426046Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
74 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Febrile Neutropenia, run by Amgen at 74 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in France, Greece, Romania, Germany, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Febrile Neutropenia (time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.