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

University of Cologne

Status and phase: Completed; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Dexamethasone; Drug: Procarbazine; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Doxorubicin; Drug: Dacarbazine; Drug: Brentuximab Vedotin

Study type: Interventional

Funder types: Other

Identifiers

NCT01569204

Targeted BEACOPP

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Exclusion criteria

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
• Previous malignancy
• Prior chemotherapy or radiation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

BrECAPP

Active Comparator group

Description:

modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin

Treatment:

Drug: Doxorubicin

Drug: Brentuximab Vedotin

Drug: Procarbazine

Drug: Prednisone

Drug: Cyclophosphamide

Drug: Etoposide

BrECADD

Active Comparator group

Description:

modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone

Treatment:

Drug: Dexamethasone

Drug: Doxorubicin

Drug: Brentuximab Vedotin

Drug: Dacarbazine

Drug: Cyclophosphamide

Drug: Etoposide