- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848926
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
March 9, 2017 updated by: Seagen Inc.
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- UZ Gasthuisberg
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Yvoir, Belgium, 5530
- Cliniques Universitaires UCL de Mont-Goddine
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- B.C Cancer Agency
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Marseille, France, 13273
- Institut Paoli Calmettes
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Paris, France, 75475
- Hospital Saint Louis
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Rouen, France, 76038
- Centre Henri Becquerel
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Bologna, Italy, 40138
- Instituto di Ematologia ed Oncologia Medica
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Alabama
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Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham
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California
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Duarte, California, United States, 91010-3000
- City of Hope National Medical Center
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Los Angeles, California, United States, 90095
- University of California at Los Angeles
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Palo Alto, California, United States, 94305
- Stanford University Medical Center
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center Cardinal Bernardin Cancer Center
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Michigan
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10021
- Weill Cornell Medical College
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Texas
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Dallas, Texas, United States, 75246
- Baylor Sammons Cancer Center
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Houston, Texas, United States, 77030-4009
- University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98109
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Brentuximab vedotin
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1.8 mg/kg every 3 weeks by intravenous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective Response Rate by Independent Review Group
Time Frame: up to 12 months
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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.
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up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Remission Rate by Independent Review Group
Time Frame: up to 12 months
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Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
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up to 12 months
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Duration of Objective Response by Kaplan-Meier Analysis
Time Frame: up to approximately 4 years
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Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
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up to approximately 4 years
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Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Time Frame: up to approximately 4 years
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Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.
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up to approximately 4 years
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Progression-free Survival by Kaplan-Meier Analysis
Time Frame: up to approximately 4 years
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Time from start of study treatment to disease progression per independent review group or death due to any cause.
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up to approximately 4 years
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Overall Survival
Time Frame: up to approximately 6 years
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Time from start of study treatment to date of death due to any cause.
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up to approximately 6 years
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Adverse Events by Severity, Seriousness, and Relationship to Treatment
Time Frame: up to 12 months
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Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose).
Serious adverse events are reported from the time of informed consent.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death).
Relatedness to study drug was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an adverse event within a category are counted once within the category.
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up to 12 months
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Hematology Laboratory Abnormalities >/= Grade 3
Time Frame: up to 12 months
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Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0.
Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
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up to 12 months
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Chemistry Laboratory Abnormalities >/= Grade 3
Time Frame: up to 12 months
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Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0.
Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
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up to 12 months
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Area Under the Curve
Time Frame: 3 weeks
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Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
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3 weeks
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Maximum Serum Concentration
Time Frame: 3 weeks
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Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
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3 weeks
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Time of Maximum Serum Concentration
Time Frame: 3 weeks
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Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
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3 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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B Symptom Resolution
Time Frame: up to 12 months
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Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.
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up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Abraham Fong, MD, PhD, Seagen Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Chen 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.
- Gopal 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
February 18, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 9, 2017
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SG035-0003
- 2008-006034-10 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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