Clinical trial NCT04460079: Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
Official title: Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Neutropenia
Keywords: Febrile neutropenia
Pegfilgrastim
Post-marketing surveillance
Chemotherapy-induced neutropenia
myelosuppressive chemotherapy
Lead sponsor: Cinnagen
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.

Brief summary: The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

Detailed description: The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

Data was gathered in two booklets, each containing information on four cycles of chemotherapy, which was filled by the designated physician. The duration of PegaGen® treatment was at the physicians' discretion based on the patient's condition.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

This study was single arm and 654 subjects participated across various tumor types and regimens.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years,
* with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician decision.

Primary outcomes:
measure: Safety assessment, using incidence according to SOC and PT of AEs and SAEs
timeFrame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.
Secondary outcomes:
measure: Effectiveness assessment: The frequency of neutropenia and neutropenic fever
timeFrame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.
Other outcomes:
Locations:
Study officials:
affiliation: Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran
name: Arash Jenabian, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jenabian A, Ehsanpour A, Mortazavizadeh SMR, Raafat J, Razavi M, Khosravi A, Seifi S, Salimi B, Anjidani N, Kafi H. Evaluating the safety and effectiveness of PegaGen(R) (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study. Support Care Cancer. 2022 Oct;30(10):8151-8158. doi: 10.1007/s00520-022-07265-2. Epub 2022 Jul 6.