A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
NCT ID: NCT03947255
Last Updated: 2023-10-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2019-10-28
2022-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brentuximab vedotin
brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Interventions
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brentuximab vedotin
1.8 mg/kg given intravenously (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment
* Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin
* Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
* Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug
Exclusion Criteria
* Existing Grade 2 or higher peripheral neuropathy
* Previously refractory to treatment with brentuximab vedotin
* History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose
* History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy
* Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
* Active cerebral/meningeal disease
* History of progressive multifocal leukoencephalopathy (PML)
* Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on 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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Dominic Lai, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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Pacific Cancer Medical Center
Anaheim, California, United States
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
Lafayette, Colorado, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Northwest Oncology and Hematology/AMITA
Elk Grove Village, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Florham Park, New Jersey, United States
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States
Texas Oncology - Fort Worth
Dallas, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders: Fortworth
Fort Worth, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Houston Methodist Cancer Center
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 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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SGN35-028
Identifier Type: -
Identifier Source: org_study_id
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