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Trial record 1 of 1 for:    2014-005130-55
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HD21 for Advanced Stages

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ClinicalTrials.gov Identifier: NCT02661503
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE January 22, 2016
Last Update Posted Date November 8, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Progression Free Survival [ Time Frame: 5 years ]
  • Treatment Related Morbidity [ Time Frame: during 6 cycles of chemotherapy (21-day cycles) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HD21 for Advanced Stages
Official Title  ICMJE HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD
Brief Summary

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).

If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

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 Classical Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: Bleomycin
  • Drug: Etoposide
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
  • Drug: Vincristine
  • Drug: Procarbazine
  • Drug: Prednisone
  • Drug: Brentuximab Vedotin
  • Drug: Dacarbazine
  • Drug: Dexamethasone
Study Arms  ICMJE
  • Active Comparator: BEACOPP
    4 or 6 cycles of BEACOPP (21-day cycles) Bleomycin (B) Etoposide (E) Doxorubicin (A) Cyclophosphamide (C) Vincristine (O) Procarbazin (P) Prednisone (P). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will bev given a total of six cycles.
    Interventions:
    • Drug: Bleomycin
    • Drug: Etoposide
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
    • Drug: Vincristine
    • Drug: Procarbazine
    • Drug: Prednisone
  • Experimental: BRECADD
    4 or 6 cycles of BRECADD (21.day cycles) Brentuximab Vedotin (BR) Etoposide (E) Cyclophosphamide (C) Doxorubicin (A) Dacarbazine (D) Dexamethasone (D). If FDG-PET is negative after two cycles patients will be given a total of four cycles. If FDG-PET is positive after two cycles patients will be given a total of six cycles.
    Interventions:
    • Drug: Etoposide
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
    • Drug: Brentuximab Vedotin
    • Drug: Dacarbazine
    • Drug: Dexamethasone
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2016)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven classical Hodgkin lymphoma
  • First diagnosis, no previous treatment, 18 to 60 years of age
  • Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

Exclusion Criteria:

  • Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
  • Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
  • Prior chemotherapy or radiotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Fuchs ghsg@uk-koeln.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02661503
Other Study ID Numbers  ICMJE Uni-Koeln-1762
2014-005130-55 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Peter Borchmann, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Borchmann, Prof. University of Cologne, I. Dept. of Medicine
PRS Account University of Cologne
Verification Date November 2019

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