Trial document





This trial has been registered retrospectively.
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  DRKS00008907

Trial Description

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Title

Non-Interventional study on treatment with Lipegfilgrastim (Lonquex®) in patients with urological malignant entities, being treated with myelotoxic chemotherapies.

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Trial Acronym

NIS Lonquex URO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Within the scope of this observational study the influence of Lonquex® on the duration of neutropenia (abnormally low number of white blood cells) and occurrence of fevered reduction in the number of white blood cells will be investigated on blood samples.
Lonquex® contains the active substance Lipegfilgrastim. It stimulates the bone marrow (the tissue where new blood cells are build) to increased formation of white blood cells.
The white blood cells are important for the body`s own defenses. These cells are very sensitive to effects of chemotherapy. That could cause reduction of white blood cells in the body. If the number of white blood cells falls below normal, are not enough cells available in the body to kill the bacteria. It may increase one`s risk of infection.
If after chemotherapy the number of white blood cells is too low, the body does not have enough of G-CSF, which is produced by the body. G-CSF (Granulocyte-colony stimulating factor) is a natural protein that is similar to the Lipegfilgrastim (long-acting modified protein). The supplementation with Lonquex® may become necessary.

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Brief Summary in Scientific Language

Rationale: Aim of this non-interventional study is the systematic evaluation of Lipegfilgrastim (Lonquex®) in routine clinical practice (for reduction in the duration of neutropenia and the incidence of febrile neutropenia) in patients with urological malignant entities under myelotoxic chemotherapy. By evaluation of the data, the efficacy of the supportive treatment with Lipegfilgrastim (Lonquex®) in routine clinical practice shall be documented.
Patient population: Patients receiving antineoplastic therapy who will be treated during the current chemotherapy line with lipegfilgrastim (Lonquex®).
Treatment: Patients will be treated according to the summary of product characteristics Lonquex®, status as of April 2014.
6 mg dose of Lipegfilgrastim is recommended per chemotherapy cycle. The subcutaneous injection will be done approximately 24 hours after chemotherapy.
Lipegfilgrastim (Lonquex®) is Europe-wide approved drug to shorten the duration of the neutropenia and to decrease the frequency of neutropenic fever in patients, whose malignant disease (except myeloid leukemia and myelodysplastic syndrome) should be treated with chemotherapy.
The ready-to-use syringe Lonquex® provides 6 mg/ml Lipegfilgrastim in 1 ml clear colourless preservative-free solution for injection (other components, which have been attributed an effect: sorbitol E420, sodium acetate).
At least one course of treatment with Lipegfilgrastim (Lonquex®) has to be supported. All enrolled patients will be monitored for a maximum of six sequential chemotherapy cycles. The final documentation will be made at the end of monitoring period, 28 days after the last injection.
Statistical aspects: The evaluation of collected parameters will be analysed with descriptive statistics.

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Organizational Data

  •   DRKS00008907
  •   2015/09/17
  •   [---]*
  •   no
  •   Approved
  •   Eth-16/15, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Observation of the application of Lonquex(R) (Lipegfilgrastim) for a period of 6 months. Collection of data e.g. about demography, patient status (ECOG), primary disease/tumor anamnesis, therapy with Lipegfilgrastim, number of leucocytes
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Characteristics

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

• severe neutropenia [NCI CTCAE grade 3 and 4, febrile neutropenia (FN)] after CTx (observation at a maximum of 6 consecutive chemotherapeutic cycles per patient)

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Secondary Outcome

• Frequency of cycle delays and dose reductions
• therapy with antibiotics-/ antimycotics
• time of injection of lipegfilgrastim (Lonquex®) per CTx cycle
• patient’s individual risk to develop febrile neutropenia
• Leukocyte counts and absolute neutrophil counts (ANC) ahead of first
application of CTx
• Leukocyte counts and absolute neutrophil counts (ANC) measured
within one week after application of CTx
• percentage of patients who self inject lipegfilgrastim (Lonquex®)
• treating physician’s opinion on overall assessment of efficacy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2015/07/24
  •   300
  •   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

- Patients receiving antineoplastic therapy who will be treated during the current chemotherapy line with lipegfilgrastim (Lonquex®) (for reduction in the duration of neutropenia or the incidence of febrile neutropenia)
- Adult male and female patients (at least 18 years with no upper age limit)
- Written informed consent to data collection and pseudonymised data transmission to the performing CRO and the sponsor.

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Exclusion Criteria

- Missing patient’s informed consent
- Treatment with another G-CSF formulation during the current line of chemotherapy
- Pregnant or breast-feeding women
- Planned myelosuppressive or myeloablative therapy with stem cell support
- Existing or newly diagnosed myelodysplastic syndrome (MDS)
- Known or newly diagnosed chronic myeloid leukemia (CML)
- Known severe chronic neutropenia, congenital neutropenia or idiopathic or cyclic neutropenia
- Known HIV infection

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Addresses

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    • Fa. Teva GmbH
    • Graf-Arco-Str. 3
    • 89079  Ulm
    • Germany
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    • OnkoDataMed GmbH
    • Ms.  Anne-Katrin  Ullner 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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    • OnkoDataMed GmbH
    • Ms.  Anne-Katrin  Ullner 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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

  •   Recruiting complete, follow-up complete
  •   2016/12/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.