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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01569204
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne

Study Description
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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

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Etoposide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Procarbazine Drug: Dexamethasone Drug: Dacarbazine Drug: Brentuximab Vedotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
 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
 Drug: Etoposide
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Dexamethasone
Drug: Dacarbazine
Drug: Brentuximab Vedotin


Outcome Measures
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Primary Outcome Measures :
  1. Response rate (RR) after six cycles of chemotherapy [ Time Frame: 18 weeks ]
  2. Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 2 years ]
  2. Overall survival (OS) [ Time Frame: 2 years ]
  3. Adverse event rate [ Time Frame: 2 years ]
  4. Dose reduction rate [ Time Frame: 18 weeks ]
  5. Relative dose intensity [ Time Frame: 18 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569204


Locations
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Germany
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Peter Borchmann, Prof. University of Cologne, German Hodgkin Study Group
More Information
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Additional Information:

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Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01569204    
Other Study ID Numbers: Targeted BEACOPP
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisone
Cyclophosphamide
Dacarbazine
Doxorubicin
Etoposide
Brentuximab Vedotin
 Procarbazine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents