Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Seagen

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Large-Cell, Anaplastic; Disease, Hodgkin; Lymphoma, Non-Hodgkin

Treatments: Drug: brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026233

SGN35-007

Details and patient eligibility

About

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed or refractory CD30-positive malignancy
• Adequate organ function
• ECOG performance status <2

Exclusion criteria

• Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
• Current diagnosis of primary cutaneous ALCL
• Acute or chronic graft-versus-host disease
• Prior hematopoietic stem cell transplant within specified timeframe

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

1

Experimental group

Description:

brentuximab vedotin

Treatment:

Drug: brentuximab vedotin