HD16 for Early Stage Hodgkin Lymphoma

This study is currently recruiting participants.
Verified January 2013 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00736320
First received: August 8, 2008
Last updated: January 25, 2013
Last verified: January 2013

August 8, 2008
January 25, 2013
November 2009
November 2013   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00736320 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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
HD16 for Early Stage Hodgkin Lymphoma
HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Lymphoma
  • Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
    chemotherapy with 2 cycles of ABVD (day 1 + 15)
  • Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
    20 Gy Involved Field Radiotherapy
  • Active Comparator: A
    2 cycles ABVD followed by 20 Gy IF-RT irrespective of FDG-PET results after chemotherapy
    Interventions:
    • Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
    • Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
  • Experimental: B
    2 cycles ABVD followed by 20 Gy IF-RT if FDG-PET is positive after chemotherapy; 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
    Interventions:
    • Drug: ABVD (Adriamycin, Bleomycin, Vincristine, Dacarbazine)
    • Radiation: 20 Gy IFRT (Involved Field Radiotherapy)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1100
Not Provided
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hodgkin Lymphoma
  • CS I, II without risk factors

    • large mediastinal mass (> 1/3 of maximum transverse thorax diameter)
    • extranodal involvement
    • elevated ESR
    • 3 or more involved nodal areas
  • Written informed consent

Exclusion Criteria:

  • Leucocytes < 3000/µl
  • Platelets < 100000/µl
  • Hodgkin Lymphoma as composite lymphoma
  • Activity index (WHO) > 2
Both
18 Years to 75 Years
No
Contact: Michael Fuchs GHSG@uk-koeln.de
Germany
 
NCT00736320
HD16
Yes
Not Provided
University of Cologne
Not Provided
Principal Investigator: Andreas Engert, Prof. University of Cologne
University of Cologne
January 2013

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