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

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	Hodgkin Lymphoma
Intervention	Drug: Etoposide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Procarbazine Drug: Dexamethasone Drug: Dacarbazine Drug: Brentuximab Vedotin
Phase	Phase 2
Sponsor	University of Cologne
Responsible Party	University of Cologne
ClinicalTrials.gov Identifier	NCT01569204
First Received	April 2, 2012
Last Updated	June 19, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	April 2, 2012
Last Updated Date	June 19, 2013
Start Date	October 2012
Estimated Primary Completion Date	December 2015
Current Primary Outcome Measures	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]
Current Secondary Outcome Measures	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]

Descriptive Information[ + expand ][ + ]

Brief Title	Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Official Title	Not Provided
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Hodgkin Lymphoma
Intervention	Drug: Etoposide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Procarbazine Drug: Dexamethasone Drug: Dacarbazine Drug: Brentuximab Vedotin
Study Arm (s)	Active Comparator: ECAPP-B Active Comparator: ECADD-B

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	100
Estimated Completion Date	December 2015
Estimated Primary Completion Date	December 2013
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Michael Fuchs ghsg@uk-koeln.de
Location Countries	Germany

Administrative Information[ + expand ][ + ]

NCT Number	NCT01569204
Other Study ID Numbers	Targeted BEACOPP
Has Data Monitoring Committee	Yes
Information Provided By	University of Cologne
Study Sponsor	University of Cologne
Collaborators	Not Provided
Investigators	Principal Investigator: Peter Borchmann, Prof. University of Cologne, German Hodgkin Study Group
Verification Date	June 2013

Locations[ + expand ][ + ]