Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

Seagen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hodgkin Disease

Treatments: Drug: bendamustine; Drug: brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874054

SGN35-016

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathological diagnosis of classical Hodgkin lymphoma
• Failed standard front-line therapy
• Measurable disease of at least 1.5 cm as documented by radiographic technique
• Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion criteria

• Received prior salvage therapy, including radiotherapy
• Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
• Concurrent use of other investigational agents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Brentuximab Vedotin + Bendamustine

Experimental group

Description:

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

Treatment:

Drug: brentuximab vedotin

Drug: bendamustine