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HD18 for Advanced Stages in Hodgkins Lymphoma

This study is currently recruiting participants.
Verified March 2012 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00515554
First received: August 10, 2007
Last updated: April 2, 2012
Last verified: March 2012
History of Changes

August 10, 2007
April 2, 2012
May 2008
May 2012   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Progression Free Survival
Complete list of historical versions of study NCT00515554 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • acute toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • late toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • CR-rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Overall Survival acute and late toxicity CR-rate
Not Provided
Not Provided
 
HD18 for Advanced Stages in Hodgkins Lymphoma
Not Provided

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkins Lymphoma
  • Drug: Rituximab
    addition of Rituximab to BEACOPP escalated
  • Drug: BEACOPP escalated
    chemotherapy with BEACOPP escalated
  • Active Comparator: A
    8 cycles BEACOPPesc
    Intervention: Drug: BEACOPP escalated
  • Experimental: B
    8 cycles BEACOPPesc plus rituximab
    Interventions:
    • Drug: Rituximab
    • Drug: BEACOPP escalated
  • Active Comparator: C
    8 cycles BEACOPPesc
    Intervention: Drug: BEACOPP escalated
  • Experimental: D
    4 cycles BEACOPPesc
    Intervention: Drug: BEACOPP escalated
Sauer M, Plütschow A, Jachimowicz RD, Kleefisch D, Reiners KS, Ponader S, Engert A, von Strandmann EP. Baseline serum TARC levels predict therapy outcome in patients with Hodgkin lymphoma. Am J Hematol. 2013 Feb;88(2):113-5. doi: 10.1002/ajh.23361. Epub 2012 Dec 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
Not Provided
May 2012   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Leucocytes < 3000/µl
  • Platelets < 100000/µl
  • Hodgkin´s lymphoma as "composite lymphoma"
  • Activity index (WHO) < grade 2
Both
18 Years to 60 Years
No
Contact: Michael Fuchs GHSG@uk-koeln.de
Germany
 
NCT00515554
HD18
Yes
Not Provided
University of Cologne
Not Provided
Principal Investigator: Andreas Engert, Prof. University of Cologne
University of Cologne
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP