Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003791

Trial Description

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Title

HLH-2004 Treatment Protocol

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Without therapy HLH is often fatal, and often rapidly fatal. The treatment protocol HLH-94
has improved survival markedly as compared to the survival earlier. We now aim to improve
survival further.

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Brief Summary in Scientific Language

The most dangerous period after HLH diagnosis is the first 2 months. In HLH-2004 we provide
additional therapy during this period as compared to in HLH-94.

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Organizational Data

  •   DRKS00003791
  •   2012/05/04
  •   2007/01/23
  •   yes
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Secondary IDs

  •   NCT00426101  (ClinicalTrials.gov)
  •   HLH-2004  (Karolinska University Hospital)
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Health Condition or Problem studied

  •   Hemophagocytic Lymphohistiocytosis
  •   D76.1 -  Haemophagocytic lymphohistiocytosis
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Interventions/Observational Groups

  •   Drug: Dexamethasone
  •   Drug: Etoposide
  •   Drug: Cyclosporin
  •   Procedure: Intrathecal therapy
  •   Procedure: Stem cell transplant
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
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Primary Outcome

- Survival; time frame: 1-year after diagnosis

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Secondary Outcome

- Late effects; time frame: At last follow-up report

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Countries of Recruitment

  •   Sweden
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Locations of Recruitment

  • [---]*
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Recruitment

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  •   2004/01/31
  •   300
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Patients who fulfil the diagnostic criteria of HLH.

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Exclusion Criteria

- Prior cytotoxic or cyclosporin treatment for HLH.

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Addresses

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    • Karolinska University Hospital
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    • Azienda Ospedaliero, Universitaria Meyer
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    • Leiden University Medical Center
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    • Children's Hospital Medical Center, Cincinnati
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    • Ehime University Graduate School of Medicine
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    • Universitätsklinikum Hamburg-Eppendorf
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    • Texas Children's Hospital
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    • Great Ormond Street Hospital for Children NHS Foundation Trust
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    • St. Anna Kinderkrebsforschung
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    • Hospital de Cruces
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    • Hospital JP Garrahan
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    • Karolinska Institutet
    • Jan-Inge Henter, MD, PhD 
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    • Karolinska Institutet
    • Jan-Inge Henter, MD, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

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

  •   Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31.; 16937360
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   9
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.