Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

NCT ID: NCT01026233

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

brentuximab vedotin

Group Type EXPERIMENTAL

brentuximab vedotin

Intervention Type DRUG

1.8 mg/kg IV every 21 days

Interventions

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brentuximab vedotin

1.8 mg/kg IV every 21 days

Intervention Type DRUG

Other Intervention Names

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SGN-35

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi Hunder, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

University of Miami Hospital and Clinics, Miller School of Medicine

Miami, Florida, United States

Site Status

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, United States

Site Status

New York University Cancer Institute

New York, New York, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

University Hospital of Cologne

Cologne, , Germany

Site Status

Countries

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United States Germany

References

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Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancies. Cancer Chemother Pharmacol. 2013 Jul;72(1):241-9. doi: 10.1007/s00280-013-2192-z. Epub 2013 May 30.

Reference Type RESULT
PMID: 23719719 (View on PubMed)

Rothe A, Sasse S, Goergen H, Eichenauer DA, Lohri A, Jager U, Bangard C, Boll B, von Bergwelt Baildon M, Theurich S, Borchmann P, Engert A. Brentuximab vedotin for relapsed or refractory CD30+ hematologic malignancies: the German Hodgkin Study Group experience. Blood. 2012 Aug 16;120(7):1470-2. doi: 10.1182/blood-2012-05-430918. Epub 2012 Jul 11.

Reference Type DERIVED
PMID: 22786877 (View on PubMed)

Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

Reference Type DERIVED
PMID: 22510871 (View on PubMed)

Other Identifiers

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SGN35-007

Identifier Type: -

Identifier Source: org_study_id