A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
NCT ID: NCT02702141
Last Updated: 2018-08-13
Study Results
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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TERMINATED
PHASE1
44 participants
INTERVENTIONAL
2016-02-29
2018-07-10
Brief Summary
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Detailed Description
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Individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the Safety Monitoring Committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SGN-CD19B
SGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles
Interventions
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SGN-CD19B
Given intravenously Day 1 of 28-day or 42-day cycles
Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* Eastern Cooperative Oncology Group status of 0 or 1
* Adequate baseline renal and hepatic function
Exclusion Criteria
* Known HIV, active hepatitis B or active hepatitis C infection
* Prior allogeneic stem cell transplant
* Inadequate lung function
* Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Juan Pinelli, PA-C, MMSc
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York University (NYU) Cancer Institute
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic, The
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Ryan MC, Palanca-Wessels MC, Schimpf B, Gordon KA, Kostner H, Meyer B, Yu C, Van Epps HA, Benjamin D. Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Blood. 2017 Nov 2;130(18):2018-2026. doi: 10.1182/blood-2017-04-779389. Epub 2017 Sep 13.
Other Identifiers
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SGN19B-001
Identifier Type: -
Identifier Source: org_study_id
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