Back to resultsTargeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Etoposide
Cyclophosphamide
Doxorubicin
Prednisone
Procarbazine
Dexamethasone
Dacarbazine
Brentuximab Vedotin
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma
Eligibility Criteria
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
Sites / Locations
- 1st Dept. of Medicine, Cologne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BrECAPP
BrECADD
Arm Description
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
Outcomes
Primary Outcome Measures
Response rate (RR) after six cycles of chemotherapy
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Secondary Outcome Measures
Progression Free Survival (PFS)
Overall survival (OS)
Adverse event rate
Dose reduction rate
Relative dose intensity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01569204
Brief Title
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BrECAPP
Arm Type
Active Comparator
Arm Description
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
Arm Title
BrECADD
Arm Type
Active Comparator
Arm Description
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Procarbazine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Primary Outcome Measure Information:
Title
Response rate (RR) after six cycles of chemotherapy
Time Frame
18 weeks
Title
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
2 years
Title
Adverse event rate
Time Frame
2 years
Title
Dose reduction rate
Time Frame
18 weeks
Title
Relative dose intensity
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Borchmann, Prof.
Organizational Affiliation
University of Cologne, German Hodgkin Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Dept. of Medicine, Cologne University Hospital
City
Cologne
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.ghsg.org
Description
Homepage GHSG
Learn more about this trial
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
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