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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01569204
Other study ID # Targeted BEACOPP
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2012
Est. completion date December 2017

Study information

Verified date October 2018
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2017
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Etoposide

Cyclophosphamide

Doxorubicin

Prednisone

Procarbazine

Dexamethasone

Dacarbazine

Brentuximab Vedotin


Locations

Country Name City State
Germany 1st Dept. of Medicine, Cologne University Hospital Cologne

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate (RR) after six cycles of chemotherapy 18 weeks
Primary Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment 18 weeks
Secondary Progression Free Survival (PFS) 2 years
Secondary Overall survival (OS) 2 years
Secondary Adverse event rate 2 years
Secondary Dose reduction rate 18 weeks
Secondary Relative dose intensity 18 weeks
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