Conditions: Hodgkin Disease
Keywords: Antibody-Drug Conjugate Antibodies, Monoclonal Hodgkin Disease Hematologic Diseases Drug Therapy Immunotherapy Antigens, CD30 Lymphoma monomethylauristatin E
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Detailed description:

Arms:
arm 1: Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles

Interventions: intervention 1: brentuximab vedotin intervention 2: bendamustine
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion intervention 2: 90 mg/m2 on Days 1 and 2 of 3-week cycles

Protocol document: