Study Complete
Sponsor ID
20120214

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

Sponsor ID
20120214
Clinicaltrials.gov ID
NCT02178475
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
N/A
Product
pegfilgrastim
Type
Observational
Masking
N/A
Enrollment
943
Additional Study Details

Protocol Summary

Primary Outcome Measures

To estimate the incidence of FN in all subjects

Timeframe: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

Secondary Outcome Measures

To describe discontinuation of pegfilgrastim prophylaxis and discontinuation of G-CSF prophylaxis in terms of reasons and frequency of subjects and cycles

Timeframe: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

To estimate the incidence of complications of FN in all subjects across all cycles

Timeframe: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

To estimate the incidence of FN and complications of FN in discontinuation of G-CSF prophylaxis cycles at the subject and cycle level

Timeframe: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

To estimate the frequency of switch from pegfilgrastim prophylaxis to other G-CSF(s)

Timeframe: Participants will be followed up for a maximum of 8 cycles of chemotherapy, an average observation period would be around 18 weeks.

Locations

Location
Status
Contact Us
Location
Research Site
Gdynia, Poland, 81-519
Status
Recruiting
Location
Research Site
Troisdorf, Germany, 53840
Status
Recruiting
Location
Research Site
Warszawa, Poland, 02-097
Status
Recruiting
Location
Research Site
Koszalin, Poland, 75-581
Status
Recruiting
Location
Research Site
Praha 10, Czech Republic, 100 34
Status
Completed
Location
Research Site
Bialystok, Poland, 15-027
Status
Recruiting
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