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HD17 for Intermediate Stage Hodgkin Lymphoma

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: NCT01356680
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

Tracking Information
First Submitted Date  ICMJE May 13, 2011
First Posted Date  ICMJE May 19, 2011
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE January 13, 2012
Actual Primary Completion Date March 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
Progression Free Survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • Overall Survival [ Time Frame: 3 years ]
  • CR rate [ Time Frame: 6 months ]
    Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
  • Overall Survival [ Time Frame: 3 years ]
  • CR rate
    Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HD17 for Intermediate Stage Hodgkin Lymphoma
Official Title  ICMJE HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma
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: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
  • Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
  • Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
  • Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)
Study Arms  ICMJE
  • Active Comparator: Arm A
    2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IF-RT irrespective of FDG-PET results after chemotherapy
    Interventions:
    • Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
    • Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
    • Radiation: 30Gy IF-RT (Involved-Field Radiotherapy)
  • Experimental: Arm B
    2 cycles BEACOPPescalated plus 2 cycles ABVD followed by 30Gy IN-RT if FDG-PET is positive after chemotherapy; 2 cycles BEACOPPescalated plus 2 cycles ABVD and treatment stop if FDG-PET is negative after chemotherapy
    Interventions:
    • Drug: BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
    • Drug: ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
    • Radiation: 30Gy IN-RT (Involved-Node Radiotherapy)
Publications * Voltin CA, Goergen H, Baues C, Fuchs M, Mettler J, Kreissl S, Oertl J, Klaeser B, Moccia A, Drzezga A, Engert A, Borchmann P, Dietlein M, Kobe C. Value of bone marrow biopsy in Hodgkin lymphoma patients staged by FDG PET: results from the German Hodgkin Study Group trials HD16, HD17, and HD18. Ann Oncol. 2018 Sep 1;29(9):1926-1931. doi: 10.1093/annonc/mdy250.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2011)
1100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 23, 2020
Actual Primary Completion Date March 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hodgkin Lymphoma
  • CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
  • 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 60 Years   (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 NCT01356680
Other Study ID Numbers  ICMJE HD17
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, German Hodgkin Study Group
PRS Account University of Cologne
Verification Date April 2020

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