Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne
ClinicalTrials.gov Identifier:
NCT01569204
First received: April 2, 2012
Last updated: December 16, 2014
Last verified: December 2014

April 2, 2012
December 16, 2014
October 2012
March 2014   (final data collection date for primary outcome measure)
  • Response rate (RR) after six cycles of chemotherapy [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01569204 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Adverse event rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Dose reduction rate [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
  • Relative dose intensity [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 2015
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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01569204
Targeted BEACOPP
Yes
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
December 2014

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