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


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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014


  • Drug: Etoposide
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Prednisone
  • Drug: Procarbazine
  • Drug: Dexamethasone
  • Drug: Dacarbazine
  • Drug: Brentuximab Vedotin

Arms, Groups and Cohorts

  • Active Comparator: BrECAPP
    • modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
  • Active Comparator: BrECADD
    • modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Cologne
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Peter Borchmann, Prof. – University of Cologne
  • Overall Official(s)
    • Peter Borchmann, Prof., Principal Investigator, University of Cologne, German Hodgkin Study Group

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