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HD16 for Early Stage Hodgkin Lymphoma (HD16)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
ClinicalTrials.gov Identifier:
NCT00736320
First received: August 8, 2008
Last updated: January 27, 2016
Last verified: January 2016

August 8, 2008
January 27, 2016
November 2009
May 2020   (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)
Narang AK, Terezakis SA. Contemporary radiation therapy in combined modality therapy for Hodgkin lymphoma. J Natl Compr Canc Netw. 2015 May;13(5):597-605. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1150
Not Provided
May 2020   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00736320
HD16
Yes
Not Provided
Not Provided
Prof. Dr. Andreas Engert, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Andreas Engert, Prof. University of Cologne
University of Cologne
January 2016

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