Trial document





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

  DRKS00003457

Trial Description

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Title

HD18 for Advanced Stages in Hodgkins Lymphoma

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This study is designed to test:

1. in patients with negative positron-emission tomography (PET) after 2 cycles of
BEACOPPesc chemotherapy: whether the number of cycles can be reduced without
compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)

2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc
chemotherapy by adding Rituximab improves PFS.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003457
  •   2012/11/21
  •   2007/08/10
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00515554  (ClinicalTrials.gov)
  •   HD18  (Universitätsklinikum Köln)
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Health Condition or Problem studied

  •   Hodgkins Lymphoma
  •   C81 -  Hodgkin's disease
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Interventions/Observational Groups

  •   Drug: Rituximab
  •   Drug: BEACOPP escalated
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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)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Progression Free Survival; time frame: 5 years

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Secondary Outcome

- Overall Survival; time frame: 5 years
- acute toxicity; time frame: 5 years
- late toxicity; time frame: 5 years
- CR-rate; time frame: 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2008/05/31
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Hodgkin Lymphoma (histologically proven)

- CS (PS) IIB with one or both of the risk factors:

- bulky mediastinal mass (> 1/3 of maximum transverse thorax diameter)

- extranodal involvement

- CS (PS) III, IV

- Written informed consent

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Exclusion Criteria

- Leucocytes < 3000/µl

- Platelets < 100000/µl

- Hodgkin´s lymphoma as "composite lymphoma"

- Activity index (WHO) < grade 2

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Addresses

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    • University of Cologne
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    •   [---]*
    •   [---]*
    •   [---]*
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    • University of Cologne
    • Andreas Engert, Prof. 
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Michael Fuchs 
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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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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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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 .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.