Trial document




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  DRKS00000218

Trial Description

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Title

Tansfusion of granulocytes for patients with febrile neutropenia

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Trial Acronym

GRANITE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The immunesystem of cancerpatients after recieving a high-dose chemotherapy or stemcelltransplantation is weak (phase of aplasia) and the patients predisposed for infectious diseases. Patients undergoing a long time of fever after such therapies can not only be treated with antibiotics and/or antimycotics.
In this clinical trial we look for compatible donors of specific immunecells (granulocytes), stimulate the donor to produce more of them, to transfer them afterwards to the patients, like a blooddonation.

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Brief Summary in Scientific Language

This trial is used to evaluate the relevance of granulocyte-transfusion for patience with neutropenic fever. Especially high risk patients after high-dose chemotherapy or stemcelltransplantation with longtime aplasia need more than antibiotics and/or antimycotics.

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Organizational Data

  •   DRKS00000218
  •   2011/05/04
  •   [---]*
  •   yes
  •   Approved
  •   10-103, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1111-9560 
  •   2009-010700-28 
  •   1453/01 
  •   Uni-Köln-478  (Prüfplancode)
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Health Condition or Problem studied

  •   C92.0 -  Acute myeloid leukaemia
  •   C91.0 -  Acute lymphoblastic leukaemia
  •   C92.1 -  Chronic myeloid leukaemia
  •   C91.1 -  Chronic lymphocytic leukaemia
  •   D46.9 -  Myelodysplastic syndrome, unspecified
  •   D47.1 -  Chronic myeloproliferative disease
  •   C82 -  Follicular [nodular] non-Hodgkin's lymphoma
  •   C83 -  Diffuse non-Hodgkin's lymphoma
  •   C84.4 -  Peripheral T-cell lymphoma
  •   C90.0 -  Multiple myeloma
  •   C81.9 -  Hodgkin's disease: Hodgkin's disease, unspecified
  •   10016288: febrile Neutropenie / Febrile neutropenia
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Interventions/Observational Groups

  •   Intervention-group:
    Transfusion of standardized apharesis-products of granulocytes on every other day/alternating days
    + standard-therapy (antibiotics/antimycotics)
  •   Control-group: standard-therapy without transfusion of granulocytes
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Measurement of temperature (auricularly or orally);
Interventiongroup: 1h before, at starting time and ending of the transfusion of granulocytes, 1h, 12h and 24h after the transfusion.
Controlgroup: 0h (equates to 1h before the transfusion in the interventiongroup), 12h and 24h
Endpoint: the normalisation of the temperature (measurement intraauricular or oral; <38°C) for 72h

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Secondary Outcome

End of neutropenia (not as a consequence of transfusions);
Value of neutrophile granulocytes in a bloodsample > 500/µl on two following days in an upward trend

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/10/01
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   75   Years
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Additional Inclusion Criteria

valid informed consent, subscribed by patient or his/her attorney
One of the following diseases:
- C92.0- acute myeloid leukaemia,
- C91.0- acute lymphoblastic leukaemia,
- C92.1- chronic myeloid leukaemia,
- C91.1- chronic lymphatic leukaemia,
- D46.9 myelodysplastic syndrome, unspecified,
- D47.1 chronic myeloproliferative disease,
- C82.- follicular (nodular) non-Hodgkin's lymphoma
- C83.- diffuse non-Hodgkin's lymphoma
- C84.4 peripheral T-cell lymphoma
- C90.0- Multiple myeloma
- C81.9 Hodgkin's lymphoma
Karnofsky Performance Status > 20%
echocardiography: ejection-fraction > 40%
creatinine clearance > 60ml/min
Pulmonary function: oxygensaturation at least 80%
therapy-refractory fever above 38°C without response to standard-therapy for 96 hours

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Exclusion Criteria

symptomatic coronary heart disease
cardial insuffiency NYHA III or IV
lungdisease with dyspnoea WHO III or IV
oxygensaturation < 80%
severe therapy-refractory arterial hypertension
non-therapy-induced neutropenia (e.g. aplastic anemia)
active psychiatric disease
severe kidney-dysfunction (creatinine-clearance < 60 ml/min)
severe hepatic-dysfunction with bilirubin > 2 mg/dl
insufficient therapy of a thyroid-dysfunction (T3/T4 out of the reference range)
Pregnancy or lactation
Noncontrollable life-threatening bleeding
Intracerebrally process leading to an increase of intracranial pressure (bleeding, infectious disease, tumour)
cerebral convulsions
Karnofsky Performance Status < 20%
participation in the clinical trial in the last 30 days
medical or psychic condition, which does nor allow the patient to participate in the clinical trial, neither subscribe an informed consent, according to a doctor's opinion

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Addresses

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    • Universität zu Köln
    • Albertus-Magnus-Platz
    • 50923  Köln
    • Germany
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    • Klinik I für Innere Medizin Universitätsklinikum Köln
    • Mr.  Prof. Dr. med.  Kai  Hübel 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Institut für Medizinische Statistik, Informatik und Epidemiologie der Universität zu Köln
    • Mr.  Priv.-Doz. Dr.  Martin  Hellmich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik I für Innere Medizin Universitätsklinikum Köln
    • Mr.  Prof. Dr. med.  Kai  Hübel 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik I für Innere Medizin Universitätsklinikum Köln
    • Mr.  Dr. med.  Maximilian  Fresen 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Institut für Klinische Immunologie und Transfusionsmedizin Universitätsklinikum Giessen
    • Mr.  Prof. Dr. med.  Ulrich  Sachs 
    • Langhansstraße 7
    • 35392  Giessen
    • Germany
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    • Klinik für Kinderheilkunde, Pädiatrische Hämatologie und Onkologie Medizinische Hochschule Hannover
    • Mr.  Priv.-Doz. Dr. med.  Lorenz  Grigull 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
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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.