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

• ClinicalTrials.gov Identifier: NCT01569204
• Recruitment Status: Completed
• First Posted: April 3, 2012
• Last Update Posted: October 29, 2018
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Prof. Dr. Peter Borchmann, University of Cologne

Tracking Information

• First Submitted Date: April 2, 2012
• First Posted Date: April 3, 2012
• Last Update Posted Date: October 29, 2018
• Study Start Date: October 2012
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 2, 2012)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 2, 2012)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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; Intervention Model: Parallel Assignment; Masking: None (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 Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: April 2, 2012): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01569204
• Other Study ID Numbers: Targeted BEACOPP
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Dr. Peter Borchmann, University of Cologne
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Cologne
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter Borchmann, Prof.; University of Cologne, German Hodgkin Study Group

• PRS Account: University of Cologne
• Verification Date: October 2018