- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569204
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
October 26, 2018 updated by: Prof. Dr. Peter Borchmann, University of Cologne
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cologne, Germany
- 1st Dept. of Medicine, Cologne University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
|
|
Active Comparator: BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (RR) after six cycles of chemotherapy
Time Frame: 18 weeks
|
18 weeks
|
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Time Frame: 18 weeks
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 2 years
|
2 years
|
Progression Free Survival (PFS)
Time Frame: 2 years
|
2 years
|
Adverse event rate
Time Frame: 2 years
|
2 years
|
Dose reduction rate
Time Frame: 18 weeks
|
18 weeks
|
Relative dose intensity
Time Frame: 18 weeks
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Borchmann, Prof., University of Cologne, German Hodgkin Study Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 2, 2012
First Submitted That Met QC Criteria
April 2, 2012
First Posted (Estimate)
April 3, 2012
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 26, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Antibiotics, Antineoplastic
- Dexamethasone
- Cyclophosphamide
- Etoposide
- Prednisone
- Doxorubicin
- Dacarbazine
- Brentuximab Vedotin
- Procarbazine
Other Study ID Numbers
- Targeted BEACOPP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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