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

Sponsor

University of Cologne (Other)

Overall Status

Completed

CT.gov ID

NCT01569204

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Drug: Etoposide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Procarbazine Drug: Dexamethasone Drug: Dacarbazine Drug: Brentuximab Vedotin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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