Trial document





This trial has been registered retrospectively.
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  DRKS00005711

Trial Description

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Title

Non-interventional study on treAtment of chemotherapy-inDuced neutropenia with LIpefilgRastim (XM22)

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Trial Acronym

NADIR

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URL of the Trial

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Brief Summary in Lay Language

Lipefilgrastim (trade name Lonquex®) is a registered drug for treatment of chemotherapy-induced neutropenia. During a chemotherapy the count of white blood cells is decreasing and so the risk of the patient, to catch an infection increases. The drug Lonquex® is a drug of the drug class called G-CSF (granulocytecolony-stimulating factor). It stimulates bone marc to produce more white blood cells and so it blocks the development of infections or helps to cure infections. Lonquex® is developed for subcutane injection and is delivered in direct-to-use injection tubes. The patients are able to applicate Lonquex® themeselves at home.
Goal of this non-interventional study is to collect data on application, efficacy and safety of Lonquex® in routine therapy and to complete available data collections from registration studies. Study participation is possible for patients suffering of a tumour for which the treating physician decides to treat the patients with a G-CSF first time and choses Lonquex® as drug. The treatment of the patients is not influenced by participation at this non-interventional study. There will only disease data and the treatment be documented by the investigator. Furthermore, the patients will be asked to fill in a questionaire on their experiences with the self-therapy of Lipegfilgrastim once during study.

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Brief Summary in Scientific Language

Lipegfilgrastim (Lonquex®) is a longlasting, recombinant produced granulocyte-colony stimulating factor (G-CSF) and helps to shorten the duration of neutropenia as well as to decrease the frequency of febrile neutropenia in patients receiving cytotoxic chemotherapy due to malignant disesase (exeptions are chronic-myelotic leucaemia and myelodysplastic syndroms). Goal of the non-interventional study to systematically collect data on application, efficacy and safety of routine treatment with Lipegfilgrastim (Lonquex®) (for reduction of febrile neutropenia as well as in existing chemotherapy-induced neutropenia) during anti-neoplastic therapy of tumour patients. Analyses of the collected data will be used to establish a supportive therapy of chemotherapy-induced neutropenia by Lipegfilgrastim (Lonquex®). Also, using a questionaire on self-application of Lipegfilgrastim by ready-to-use-tubes will be used to collect patient's experiences in application.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005711
  •   2014/06/23
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  •   no
  •   Approved
  •   F-2013-073 , Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   D70 -  Agranulocytosis
  •   neutropenia (chemotherapy-induced)
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Interventions/Observational Groups

  •   6 mg lipefilgrastim s.c. per chemotherapy cycle

    Observation period: Maximum 6 months
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

To evaluate the safety and efficacy profile of lipefilgrastim (XM22) for prophylaxis and/or therapy of chemotherapy-induced neutropenia during routine use.
(Time frame: Maximum 6 months)

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Secondary Outcome

• To evaluate the efficacy of lipefilgrastim (XM22) (Time frame: Maximum 6 months)

• To assess the time of injection of lipefilgrastim (XM22) per chemotherapy cycle
(Time frame: Maximum 6 months)

• To assess the incidence of febrile neutropenia (FN), neutropenia and resulting complications (Time frame: Maximum 6 months)

• To assess the patient individual risk to develop febrile neutropenia
(Time frame: Maximum 6 months)

• To evaluate the use of antibiotics and/or antiomycotics (prophylactic and/or therapeutic) (Time frame: Maximum 6 months)

• To evaluate leukocyte counts and absolute neutrophil counts (ANC) as measured in daily clinical practice (Time frame: Maximum 6 months)

• To evaluate the patients experience with lipefilgrastim (XM22) injection (Time frame: Maximum 6 months)

• To evaluate the treating physician’s opinion on efficacy and safety of lipefilgrastim (XM22)
(Time frame: Maximum 6 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2014/01/15
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Patients receiving antineoplastic therapy who will be treated for the first time with lipefilgrastim (XM22) for prevention or therapy of chemotherapy-induced neutropenia in the current treatment cycle
2. Adult male and female patients (at least 18 years with no upper age limit)
3. Written informed consent to collecting and pseudonymized data transmission.

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Exclusion Criteria

1. Prior treatment with lipefilgrastim (XM22)
2. Missing patient’s informed consent
3. Treatment with another G-CSF formulation during the current line of chemotherapy
4. Pregnant or breast-feeding women
5. Planned myelosuppressive or myeloablative therapy with stem cell support
6. Existing or newly diagnosed myelodysplastic syndrome (MDS), chronic myeloid (CML) or acute myeloid leukemia (AML)
7. Known severe chronic neutropenia, congenital neutropenia or idiopathic or cycle neutropenia
8. Known HIV positivity

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Addresses

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    • TEVA GmbH
    • Graf-Arco-Str. 3
    • 89079  Ulm
    • Germany
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    • Praxis für interdisziplinäre Onkologie & Hämatologie GbR
    • Ms.  Dr.  Matthias  Zaiss 
    • Breisacherstr. 117
    • 79106  Freiburg
    • Germany
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    • Praxis für interdisziplinäre Onkologie & Hämatologie GbR
    • Ms.  Dr.  Matthias  Zaiss 
    • Breisacherstr. 117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • TEVA GmbH
    • Graf-Arco-Str. 3
    • 89079  Ulm
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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