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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Cologne
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01569204
First received: April 2, 2012
Last updated: June 19, 2013
Last verified: June 2013
  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:


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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT01569204     History of Changes
Other Study ID Numbers: Targeted BEACOPP
Study First Received: April 2, 2012
Last Updated: June 19, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Dexamethasone
Procarbazine
Alkylating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014