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

Overview

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

Interventions

  • 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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.