Trial document
DRKS00000313
Trial Description
Title
HEXAFIL: Non-interventional study for supportive treatment of chemotherapy induced neutopenia with Filgrastim HEXAL®
Trial Acronym
HEXAFIL
URL of the Trial
Brief Summary in Lay Language
The aim of this non-interventional study is the systematic collection of data from the intended prophylactic and secondary-prophylactic use of Filgrastim HEXAL® to support the antineoplastic therapy of cancer patients.
Brief Summary in Scientific Language
Chemotherapy induced neutropenia are a common complication in the course of systemic antineoplastic chemotherapy of different tumor entities. For the development of chemotherapy induced neutropenia as well as the individual response to the treatment, different factors (eg, neoplasms, treatment, medical history, demographic factors) are held responsible for. The human Granulocyte-Stimulating Factor (G-CSF) is a peptide hormone and haematopoietic growth factor that is involved in promoting the proliferation and differentiation of progenitor cells to mature neutrophils. The systematic collection of data from the routine use of biosimilar Figrastim HEXAL® will allow for a more comprehensive data collection of efficacy and safety of Filgrastim HEXAL®.
Organizational Data
- DRKS00000313
- 2010/01/18
- [---]*
- no
- Approved
- FF99/2009, Ethikkommission der Landesärztekammer Hessen
Secondary IDs
- U1111-1113-2795
Health Condition or Problem studied
- chemotherapy induced neutropenia
- D70.1 - message.icd10.coding.redirected.en
Interventions/Observational Groups
- [---]*
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Other
- Single (group)
- N/A
- [---]*
Primary Outcome
Safety profile of Filgrastim HEXAL®
Secondary Outcome
Efficacy of Filgrastim HEXAL® treatment - application period of Filgrastim HEXAL® (measured as number of days applied per chemotherapy cycle); occurrence of febrile neutropenia, leukocyte count observed before the start of chemotherapy cycle (if available) and lowest leukocyte count observed during the chemotherapy cycle (if available); correlation of Filgrastim HEXAL® administration to tumor entitiy and previous therapy regimen; supportive treatment with antibiotics / fungicides ; assessment of self-administration of Filgrastim HEXAL® (s.c.) by the patients, assessment of the needle protection system; overall rating for efficacy and tolerability by the responsible physician.
Additional secundary parameters in line with the Amendment No. 1, active since 08/17/2011:
Analysis of the ANC (absolute neutrophil count) before and lowest ANC during the observed chemotherapy cycle; intention of supportive antibiotics/antimycotics therapy
Countries of Recruitment
- Germany
Locations of Recruitment
- [---]*
Recruitment
- Actual
- 2010/01/29
- 1460
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
1.) Patients undergoing antineoplastic therapy and who are treated either prophylactically or interventionally with Filgrastim HEXAL® in case of emerging neutropenia.
2.) Male and female patients at least 18 years old (no upper age limit)
3.) Signed informed consent of the patient to the collection and forwarding of pseudonymised data
Exclusion Criteria
1.) Contraindication according Summary of Products Characteristics (SPC) Filgrastim HEXAL®
2.) Furthermore, patients should not be included in the non-interventional study if they fulfill at least one of the following criteria:
a.) Patients who have not signed the informed consent form
b.) Patients who have been treated with G-CSF in the current line of chemotherapy treatment
c) Female patients who are pregnant or breast-feeding
d.) Patients undergoing myelosuppressive or myeloablative therapy followed by autologous transplantation of PBBC, and
e.) Patients who are diagnosed with myelodysplastic syndrome (MDS)
f.) Patients who are diagnosed with chronic myelogenous leukemia (CML)
g.) Patients who are diagnosed with secondary AML
h.) Patients who are scheduled for myeloablative treatment followed by bone marrow transplantation
i). Patients who are diagnosed with severe chronic neutropenia (SCN), congenital neutropenia, or idiopathic or cyclic neutropenia
j.) Patients aged < 55 year who are diagnosed with de novo AML with good cytogenetics [t(8;21), t(15;17), and inv(16)]
k.) Patients who are diagnosed with HIV
l.) Patients who are diagnosed with hereditary fructose intolerance
In line with the Amendment No. 1 (approved by CEC on 06/28/2011), active since 08/17/2011:
m). Patients who have been treated with filgrastim HEXAL® for the treatment of chemotherapy-induced neutropenia and who already participated in the non-interventional study HEXAFIL
Addresses
-
start of 1:1-Block address primary-sponsor
- HEXAL AG Deutschland
- Industriestr. 25
- 83607 Holzkirchen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 08024-9082159
- 08024-9081909
- [---]*
- http://www.hexal.de/
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
- Mr. Prof. Dr. med. Hans Tesch
- Im Prüfling 17 -19
- 60389 Frankfurt
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 069-451080
- 069-458257
- [---]*
- http://www.onkologie-bethanien.de/front_content.php?idart=1
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
- Mr. Prof. Dr. med. Hans Tesch
- Im Prüfling 17 -19
- 60389 Frankfurt
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 069-451080
- 069-458257
- [---]*
- http://www.onkologie-bethanien.de/front_content.php?idart=1
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- HEXAL AG Deutschland
- Industriestr. 25
- 83607 Holzkirchen
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 08024-9082159
- 08024-9081909
- [---]*
- http://www.hexal.de/
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2013/06/30