Trial document





This trial has been registered retrospectively.
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  DRKS00017218

Trial Description

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Title

Prospective, non-interventional, open-label study on the prophylactic use of a pegylated filgrastim (Pelgraz®) to reduce the duration of neutropenia and the incidence of febrile neutropenia under conventional chemotherapy for the treatment of haematological malignancies and solid tumors

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Trial Acronym

PROOF

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Prospective, non-interventional, open-label study on the prophylactic use of a pegylated filgrastim (Pelgraz®) to reduce the duration of neutropenia and the incidence of febrile neutropenia under conventional chemotherapy for the treatment of haematological malignancies and solid tumors.

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Brief Summary in Scientific Language

The aim is to examine the frequency of occurrence of febrile neutropenia under primary prophylaxis with pegfilgrastim (Pelgraz®) considering the day of Pelgraz® administration.

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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

  •   DRKS00017218
  •   2019/05/29
  •   [---]*
  •   no
  •   Approved
  •   2018375, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   febrile neutropenia
  •   D70.0 -  [generalization D70: Agranulocytosis]
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Interventions/Observational Groups

  •   Patients (≥18 years) with haematological malignancies or solid tumors (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome) and with an overall risk for febrile neutropenia of > 20 % or an intermediated risk between ≥10 to 20 % with individual risk factors who are routinely and prophylactically treated with Pelgraz® according to the SmPC either as an initial G-CSF or as a switch from another G-CSF.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim is to examine the frequency of occurrence of febrile neutropenia under primary prophylaxis with pegfilgrastim (Pelgraz®) considering the day of Pelgraz® Administration.

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Secondary Outcome

Determination of the percentage of patients developing a febrile neutropenia and / or where the dose of chemo therapy of the next cycle is reduced or the next therapy cycle is postponed, considering the day of Pelgraz® administration. Determination of the frequency of febrile neutropenia under secondary prophylaxis with pegfilgrastim (Pelgraz®) considering the day of Pelgraz® administration. Determination of the percentage of patients receiving p.o / i.v. anti-infective agents and / or being hospitalized due to febrile neutropenia or infections, considering the day of Pelgraz® administration. Determination of the frequency of switches from another G-CSF to Pelgraz® and the reasons therefore. Validity of predictive factors for febrile neutropenia (with hospitalization) or infections (with hospitalization) under G-CSF prophylaxis based on the following criteria:
• Chemotherapy (dose-dense versus not-dose-dense with a cycle of more than 14 days)
• Patients with the following risk factors:
o Age > 65 years
o Advanced cancer
o Previous febrile neutropenia
o Female
o Reduced general condition (high ECOG, low Karnofsky index)
o poor nutritional status
o limited immune function
Frequency of occurrence of adverse drug reactions compared to the information described in the SmPC for Pelgraz®.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2019/03/27
  •   750
  •   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

Male or female patients ≥18 years with haematological malignancies or solid tumors who receive a conventional cytotoxic chemotherapy and who are treated prophylactically with Pelgraz® according to the SmPC.

Risk of febrile neutropenia between ≥ 10% and 20% (with individual risk factors) as assessed by the attending physician or overall FN risk of > 20%.

Written informed consent given by the patient or by relatives / caregivers for the retro- and prospective collection, transfer and analysis of pseudonymized data as well as for verification of patient data during a monitoring visit.

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Exclusion Criteria

Hypersensitivity to pegfilgrastim or to any other ingredient of Pelgraz®

Patients with severe congenital neutropenia who develop leukemia or who show signs of leukemia

Patients with myelodysplasia or chronic myelotic leukaemia

Patients with a recent history of pulmonary infiltrates or pneumonia

For female patients: pregnancy or breastfeeding

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Addresses

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    • ACCORD Healthcare GmbH
    • Ms.  Elen  Baumann 
    • Hansastr. 32
    • 80686  München
    • Germany
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    • ACCORD Healthcare GmbH
    • Ms.  Elen  Baumann 
    • Hansastr. 32
    • 80686  München
    • Germany
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    • ACCORD Healthcare GmbH
    • Ms.  Elen  Baumann 
    • Hansastr. 32
    • 80686  München
    • Germany
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Sources of Monetary or Material Support

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    • ACCORD Healthcare GmbH
    • Ms.  Elen  Baumann 
    • Hansastr. 32
    • 80686  München
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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