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

This study is currently recruiting participants.
Verified November 2012 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01569204
First received: April 2, 2012
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  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 Intervention Phase
Hodgkin Lymphoma
 Drug: Etoposide
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Prednisone
Drug: Procarbazine
Drug: Dexamethasone
Drug: Dacarbazine
Drug: Brentuximab Vedotin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cologne:

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 ]

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 ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ECAPP-B Drug: Etoposide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Procarbazine Drug: Brentuximab Vedotin
Active Comparator: ECADD-B Drug: Etoposide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Dexamethasone Drug: Dacarbazine Drug: Brentuximab Vedotin

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569204

Contacts
Contact: Michael Fuchs ghsg@uk-koeln.de

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Peter Borchmann, Prof.         ghsg@uk-koeln.de    
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Peter Borchmann, Prof. University of Cologne, German Hodgkin Study Group
  More Information

Additional Information:
Homepage GHSG  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01569204     History of Changes
Other Study ID Numbers: Targeted BEACOPP
Study First Received: April 2, 2012
Last Updated: November 7, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Dacarbazine
Dexamethasone
Doxorubicin
Etoposide
Prednisone
Procarbazine
 Antibodies, Monoclonal
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 19, 2013