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Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569204
First Posted: April 3, 2012
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne
April 2, 2012
April 3, 2012
May 11, 2017
October 2012
March 2014   (Final data collection date for primary outcome measure)
  • Response rate (RR) after six cycles of chemotherapy [ Time Frame: 18 weeks ]
  • Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment [ Time Frame: 18 weeks ]
Same as current
Complete list of historical versions of study NCT01569204 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: 2 years ]
  • Overall survival (OS) [ Time Frame: 2 years ]
  • Adverse event rate [ Time Frame: 2 years ]
  • Dose reduction rate [ Time Frame: 18 weeks ]
  • Relative dose intensity [ Time Frame: 18 weeks ]
Same as current
Not Provided
Not Provided
 
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Not Provided

The Purpose of this trial is:

  • to determine complete response rate (CRR) after six cycles of chemotherapy
  • to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hodgkin Lymphoma
  • Drug: Etoposide
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Prednisone
  • Drug: Procarbazine
  • Drug: Dexamethasone
  • Drug: Dacarbazine
  • Drug: Brentuximab Vedotin
  • Active Comparator: BrECAPP
    modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
    Interventions:
    • Drug: Etoposide
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Prednisone
    • Drug: Procarbazine
    • Drug: Brentuximab Vedotin
  • Active Comparator: BrECADD
    modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
    Interventions:
    • Drug: Etoposide
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Dexamethasone
    • Drug: Dacarbazine
    • Drug: Brentuximab Vedotin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2017
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
  • Previous malignancy
  • Prior chemotherapy or radiation
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01569204
Targeted BEACOPP
Yes
Not Provided
Not Provided
Prof. Dr. Peter Borchmann, University of Cologne
University of Cologne
Not Provided
Principal Investigator: Peter Borchmann, Prof. University of Cologne, German Hodgkin Study Group
University of Cologne
May 2017

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