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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 : Active, not recruiting
First Posted : April 3, 2012
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : March 2014
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

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

Additional Information:
Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01569204     History of Changes
Other Study ID Numbers: Targeted BEACOPP
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Cyclophosphamide
Doxorubicin
Etoposide
Procarbazine
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors