Trial document




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  DRKS00000043

Trial Description

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Title

Assessment of the inflammation of oral mucosa in lymphoma patients receiving Palifermin after high-dose conditioning with BEAM and autologous peripheral blood stem cell transplantation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Oral mucositis assessment in lymphoma patients receiving Palifermin vs. BSC (standard-care mucositis management) after high-dose conditioning with BEAM and autologous peripheral blood stem cell transplantation, Phase IV study

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Brief Summary in Scientific Language

Oral mucositis is a frequent and severe complication of high-dose chemotherapy. The rate of oral mucositis published in the literature is varying greatly, depending on the high-dose conditioning used and various other risk factors. In this study, 76 lymphoma patients who receive high-dose conditioning with BEAM followed by stem cell transplantation will be randomised either to receive palifermin and best supportive care or best supportive care alone. The rate, duration and intensity of oral mucositis will be compared between the 2 groups.

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Organizational Data

  •   DRKS00000043
  •   2008/11/06
  •   2008/07/07
  •   yes
  •   Approved
  •   157/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2008-001833-87 
  •   UKF001659  (Register klinischer Studien des Universitätsklinikums Freiburg)
  •   4034237 
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Health Condition or Problem studied

  •   C81 -  Hodgkin's disease
  •   C82 -  Follicular [nodular] non-Hodgkin's lymphoma
  •   C83 -  Diffuse non-Hodgkin's lymphoma
  •   C84 -  Peripheral and cutaneous T-cell lymphomas
  •   C85 -  Other and unspecified types of non-Hodgkin's lymphoma
  •   C88 -  Malignant immunoproliferative diseases
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Interventions/Observational Groups

  •   The patients receive the common and established prophylaxis (effecive oral hygiene like teeth brushing, oral rinsing) to avoid Muskositis. ("Best Supportive Care (BSC)")

    Examination of the oral cavity
    Temperature
    Blood samples (Leucocyte number)
    Duration of neutropenic fiever
  •   In addition to the common and established prophylaxis (effective oral hygiene like teeth brushing, oral rinsing) the patients receive Palifermin to avoid Muskositis.

    Examination of the oral cavity
    Temperature
    Blood samples (Leucocyte number)
    Duration of febrile neutropenia
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

Incidence of severe oral mucositis (WHO grade 3/4)
Incidence of severe oral mucositis (WHO grade 3/4) whithin 30 days after autologous PBSCT

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Secondary Outcome

Secondary endpoints: comparison of Palifermin and Best Supportive Care in regard to secondary targets:
• Duration of a severe oral mucositis (WHO grade 3/4)
• Time span to the beginning of a severe oral mucositis
• Incidence, duration and time to the development of an oral mucositis grade 2, 3, or 4
• Incidence and duration of a febrile neutropenia (leukocytes <1000/µl and body temperature >38,5C°)
• Consumption of opioid analgesics (frequency, total dose, time period)
• Incidence and duration of complete parenteral nutrition

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2008/08/21
  •   73
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

primary high-grade lymphoma
> 2 risk factors according to IPI
refractory NHL/Hodgkin
all Burkitt's lymphoma (<30% bone marrow infiltration)
all chemotherapy sensitiv NHL- and Hodgkin-relapse
KI >60%
Life expectancy > 3 months

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Exclusion Criteria

known CNS involvement
HIV disease or immunologic deficiency
severe concomitant disease
severe psychiatric illness
prior therapy with palifermin
hypersensitivity to one of the trial drugs
pregnancy, lactation, positive pregnancy test

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Innere Medizin I Hämatologie und Onkologie
    • Ms.  Prof. Dr. med.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Innere Medizin I Hämatologie und Onkologie
    • Ms.  Prof. Dr. med.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • AMGEN GmbH
    • Hanauer Straße 1
    • 80992  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/07/01
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Trial Publications, Results and other Documents

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