Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01026233

Enrollment

Registered

2009-12-04

Start date

2010-01-31

Completion date

2011-08-31

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic

Brief summary

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.

Interventions

DRUGbrentuximab vedotin

1.8 mg/kg IV every 21 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
QTc interval	2-4 days postdose

Secondary

Measure	Time frame
Incidence of adverse events and laboratory abnormalities	Through 1 month following last dose
ECG parameters	2-4 days postdose
Blood MMAE levels	Through 4 days postdose
Incidence of proarrhythmic adverse events	Through 1 month following last dose

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026