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HD16 for Early Stage Hodgkin Lymphoma (HD16)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736320
Recruitment Status : Active, not recruiting
First Posted : August 15, 2008
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

Tracking Information
First Submitted Date  ICMJE August 8, 2008
First Posted Date  ICMJE August 15, 2008
Last Update Posted Date November 4, 2020
Study Start Date  ICMJE November 2009
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
Progression Free Survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
  • overall survival [ Time Frame: 5 years ]
  • acute toxicity [ Time Frame: 5 years ]
  • late toxicity [ Time Frame: 5 years ]
  • CR rate [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
Overall survival, acute and late toxicity, CR-rate [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HD16 for Early Stage Hodgkin Lymphoma
Official Title  ICMJE HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 27, 2016)
1150
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2008)
1100
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00736320
Other Study ID Numbers  ICMJE HD16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Andreas Engert, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Engert, Prof. University of Cologne
PRS Account University of Cologne
Verification Date November 2020

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