Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
NCT ID: NCT02855359
Last Updated: 2019-03-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
24 participants
INTERVENTIONAL
2016-08-31
2018-05-15
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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denintuzumab mafodotin + RCHOP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
denintuzumab mafodotin + RCHP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
denintuzumab mafodotin + RCHOP or RCHP
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
RCHOP
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Interventions
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denintuzumab mafodotin
SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Eligibility Criteria
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Inclusion Criteria
* patients must have high intermediate or high risk disease
* Tumor tissue available from most recent biopsy to determine cell of origin
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
* Eastern Cooperative Oncology Group performance status ≤2
* Age 18 years or older
* Adequate study baseline laboratory parameters
Exclusion Criteria
* History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
* History of progressive multifocal leukoencephalopathy
* Cerebral/meningeal disease related to the underlying malignancy
* Patients with the following ocular conditions: corneal disorders, monocular vision (ie. 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 Alabama at Birmingham
Birmingham, Alabama, United States
Saint Bernards Cancer Center
Jonesboro, Arkansas, United States
City of Hope
Duarte, California, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
University of Colorado Health Memorial Hospital
Colorado Springs, Colorado, United States
Poudre Valley Hospital Harmony Campus
Fort Collins, Colorado, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hattiesburg Clinic (Forrest General Hospital)
Hattiesburg, Mississippi, United States
Research Medical Center
Kansas City, Missouri, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center - Bronx
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Tennessee Oncology / Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor Health - Baylor University Medical Center
Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Scott and White Memorial Hospital - Temple
Temple, Texas, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Vista Oncology INC PS
Olympia, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Ponce Medical School Foundation
Ponce, , Puerto Rico
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-004
Identifier Type: -
Identifier Source: org_study_id
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