Trial record 2 of 4 for:    brentuximab cologne

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne
ClinicalTrials.gov Identifier:
NCT01569204
First received: April 2, 2012
Last updated: December 16, 2014
Last verified: December 2014
  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
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

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:
No publications provided

Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT01569204     History of Changes
Other Study ID Numbers: Targeted BEACOPP
Study First Received: April 2, 2012
Last Updated: December 16, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Dexamethasone
Procarbazine
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015