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Brentuximab Vedotin or B-CAP in Older Classical Hodgkin Lymphoma
NCT02191930Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2015
- Primary completion
- Mar 2022
- Countries
- 1
- Sponsor
- University of Cologne
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- brentuximab vedotin
- Conditions
- classical Hodgkin lymphoma (cHL)
01
Overview
Phase 2, open-label trial of brentuximab vedotin in classical Hodgkin lymphoma (cHL) (2 arms), sponsored by University of Cologne. Primary endpoint: Objective Response Rate. Started Sep 2015; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
B-CAP
Brentuximab vedotin + Cyclophosphamide + Doxorubicin + Prednisolone
Brentuximab Vedotin only
Brentuximab vedotin monotherapy
03
Who it enrols
Patients aged 60 or older with newly diagnosed classical Hodgkin Lymphoma. Allocation is risk-stratified: Patients with ECOG <= 2 (or 3 if due to HL) and CIRS-G score <= 6 receive B-CAP. Patients with CIRS-G >= 7 or not eligible for poly-chemotherapy receive Brentuximab Vedotin monotherapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Progression-Free Survival
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