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)
2 other identifiers
interventional
102
5 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2009
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedResults Posted
Study results publicly available
October 26, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 13, 2017
June 1, 2015
1.5 years
February 18, 2009
September 15, 2011
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate by Independent Review Group
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
up to 12 months
Secondary Outcomes (11)
Complete Remission Rate by Independent Review Group
up to 12 months
Duration of Objective Response by Kaplan-Meier Analysis
up to approximately 4 years
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
up to approximately 4 years
Progression-free Survival by Kaplan-Meier Analysis
up to approximately 4 years
Overall Survival
up to approximately 6 years
- +6 more secondary outcomes
Other Outcomes (1)
B Symptom Resolution
up to 12 months
Study Arms (1)
Brentuximab vedotin
EXPERIMENTALInterventions
1.8 mg/kg every 3 weeks by intravenous infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
- Millennium Pharmaceuticals, Inc.collaborator
Study Sites (27)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
City of Hope National Medical Center
Duarte, California, 91010-3000, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
University of Miami
Miami, Florida, 33136, United States
Loyola University Medical Center Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
University of Washington
Seattle, Washington, 98109, United States
UZ Gasthuisberg
Leuven, 3000, Belgium
Cliniques Universitaires UCL de Mont-Goddine
Yvoir, 5530, Belgium
B.C Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Institut Paoli Calmettes
Marseille, 13273, France
Hospital Saint Louis
Paris, 75475, France
Centre Henri Becquerel
Rouen, 76038, France
Instituto di Ematologia ed Oncologia Medica
Bologna, 40138, Italy
Related Publications (3)
Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.
PMID: 22454421RESULTChen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.
PMID: 27432875DERIVEDGopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.
PMID: 25533035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seattle Genetics, Inc.
Study Officials
- STUDY DIRECTOR
Abraham Fong, MD, PhD
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 20, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2010
Study Completion
May 1, 2015
Last Updated
March 13, 2017
Results First Posted
October 26, 2011
Record last verified: 2015-06