Trial document




drksid header

  DRKS00000313

Trial Description

start of 1:1-Block title

Title

HEXAFIL: Non-interventional study for supportive treatment of chemotherapy induced neutopenia with Filgrastim HEXAL®

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

HEXAFIL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://nicht vorhanden

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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®.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000313
  •   2010/01/18
  •   [---]*
  •   no
  •   Approved
  •   FF99/2009, Ethikkommission der Landesärztekammer Hessen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1113-2795 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   chemotherapy induced neutropenia
  •   D70.1 -  message.icd10.coding.redirected.en
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Safety profile of Filgrastim HEXAL®

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/01/29
  •   1460
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • HEXAL AG Deutschland
    • Industriestr. 25
    • 83607  Holzkirchen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    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-contact
    start of 1:1-Block address contact scientific-contact
    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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

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 materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/06/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.