Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma
NCT ID: NCT02592876
Last Updated: 2019-05-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
81 participants
INTERVENTIONAL
2015-10-31
2018-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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19A+RICE
Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide
denintuzumab mafodotin
Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.
rituximab
375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles
ifosfamide
5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
carboplatin
AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles
etoposide
100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles
RICE
Rituximab, ifosfamide, carboplatin, and etoposide
rituximab
375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles
ifosfamide
5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
carboplatin
AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles
etoposide
100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles
Interventions
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denintuzumab mafodotin
Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.
rituximab
375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles
ifosfamide
5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
carboplatin
AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles
etoposide
100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
* Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
* Achieved a response of stable disease, partial response, or complete response following the last cycle of frontline treatment. In addition, patients must have relapsed less than or equal to 6 months from the completion of frontline therapy at the time of initial dosing in this clinical trial.
* Considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
* Fluorodeoxyglucose (FDG)-avid disease by positive emission tomography (PET), and measurable disease greater than 1.5 cm in diameter
* Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
* Adequate kidney and hematologic function assessed from baseline laboratory data
Exclusion Criteria
* History of autologous or allogeneic stem cell transplant
* History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy that has not been definitively treated
* Known urinary tract obstruction
* Patients with the following ocular conditions: corneal disorders, monocular vision (i.e., best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring 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 Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope National Medical Center
Duarte, California, United States
Scripps Mercy Cancer Center
San Diego, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Shands Cancer Center / University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin (Milwaukee)
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN19A-003
Identifier Type: -
Identifier Source: org_study_id
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