Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Seagen Inc.52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin

Interventions

brentuximab vedotinDRUG

1.8 mg/kg IV every 21 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

Stanford Cancer Center

Stanford, California, United States

Outcomes

Primary Outcomes

QTc interval

Time frame: 2-4 days postdose

Secondary Outcomes

ECG parameters

Time frame: 2-4 days postdose

Blood MMAE levels

Time frame: Through 4 days postdose

Incidence of proarrhythmic adverse events

Time frame: Through 1 month following last dose

Incidence of adverse events and laboratory abnormalities

Time frame: Through 1 month following last dose

Data from ClinicalTrials.gov

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