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

Phase 2

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Etoposide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Dexamethasone; Drug: Dacarbazine; Drug: Procarbazine; Drug: Brentuximab Vedotin

• Registration Number: NCT01569204
• Lead Sponsor: University of Cologne

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-03
• Study Start: 2012-10
• Primary Completion: 2014-03
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BrECAPP	Etoposide	modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECADD	Brentuximab Vedotin	modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
BrECAPP	Cyclophosphamide	modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECADD	Dacarbazine	modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
BrECAPP	Prednisone	modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECAPP	Doxorubicin	modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECAPP	Procarbazine	modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECAPP	Brentuximab Vedotin	modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
BrECADD	Doxorubicin	modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
BrECADD	Etoposide	modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
BrECADD	Dexamethasone	modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
BrECADD	Cyclophosphamide	modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone

Primary Outcome Measures

Name	Time	Method
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment	18 weeks
Response rate (RR) after six cycles of chemotherapy	18 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse event rate	2 years
Relative dose intensity	18 weeks
Progression Free Survival (PFS)	2 years
Dose reduction rate	18 weeks
Overall survival (OS)	2 years

Trial Locations

Locations (1)

1st Dept. of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany