Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 29, 2018
October 1, 2018
1.4 years
April 2, 2012
October 26, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Response rate (RR) after six cycles of chemotherapy
18 weeks
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
18 weeks
Secondary Outcomes (5)
Progression Free Survival (PFS)
2 years
Overall survival (OS)
2 years
Adverse event rate
2 years
Dose reduction rate
18 weeks
Relative dose intensity
18 weeks
Study Arms (2)
BrECAPP
ACTIVE COMPARATORmodified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECADD
ACTIVE COMPARATORmodified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Previous malignancy
- Prior chemotherapy or radiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Borchmann, Prof.
University of Cologne, German Hodgkin Study Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
April 2, 2012
First Posted
April 3, 2012
Study Start
October 1, 2012
Primary Completion
March 1, 2014
Study Completion
December 1, 2017
Last Updated
October 29, 2018
Record last verified: 2018-10