A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
2 other identifiers
interventional
110
2 countries
17
Brief Summary
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
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 Jul 2009
Typical duration for phase_2
17 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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 26, 2014
CompletedFebruary 2, 2017
December 1, 2016
3.7 years
July 24, 2009
March 21, 2014
December 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response Rate by Investigator
Percentage of participants in the retreatment arm 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 approximately 38 months
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). 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.
up to 39 months
Laboratory Abnormalities >/= Grade 3
Counts of study participants with post-baseline 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.
Up to 39 months
Secondary Outcomes (4)
Duration of Objective Response by Kaplan-Meier Analysis
Up to 38 months
Progression-free Survival by Kaplan-Meier Analysis
Up to approximately 29 months
Overall Survival
Up to approximately 41 months
Incidence of Antitherapeutic Antibodies
Up to 39 months
Study Arms (2)
BV Retreatment
EXPERIMENTALBrentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
BV Extension
EXPERIMENTALBrentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
Interventions
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
Eligibility Criteria
You may qualify if:
- Participated in a previous brentuximab vedotin study.
- CD30-positive hematologic malignancy.
- At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
You may not qualify if:
- Withdrew consent to participate in any prior brentuximab vedotin study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
- Millennium Pharmaceuticals, Inc.collaborator
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Stanford Cancer Center
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Loyola University Medical Center - Cardinal Bernadin Cancer Center
Maywood, Illinois, 60153, United States
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, 46237, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10019, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center /The University of Texas
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, 98109-1023, United States
Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, 75475, France
Related Publications (2)
Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24.
PMID: 24642247RESULTGopal 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.
PMID: 22510871DERIVED
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
Laurie Grove, PA-C
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 28, 2009
Study Start
July 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 2, 2017
Results First Posted
May 26, 2014
Record last verified: 2016-12