Loading clinical trials...

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

NCT00848926•Seagen Inc.

Summary

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
•Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
•Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
•At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria

•Previous treatment with brentuximab vedotin.
•Previously received an allogeneic transplant.
•Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
•History of another primary malignancy that has not been in remission for at least 3 years.
•Known cerebral/meningeal disease.

Locations (27)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

University of California at Los Angeles

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Georgetown University

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

August 1, 2010

Completion Date

May 1, 2015

Last Updated

March 13, 2017

Enrollment

102

ACTUAL participants

Conditions

Disease, Hodgkin

Interventions

brentuximab vedotin

DRUG

A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

NCT01196208

Disease, HodgkinLymphoma, Large-Cell, Anaplastic+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions