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

Hodgkin Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569204
• Other study ID #: Targeted BEACOPP
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

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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