Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
NCT ID: NCT02112526
Last Updated: 2024-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2014-08-07
2024-10-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acalabrutinib
Acalabrutinib
Interventions
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Acalabrutinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed de novo ABC DLBCL
* Relapsed or refractory disease
* Subjects must have ≥ 1 measurable disease sites
Exclusion Criteria
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF \< 50%
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant
18 Years
ALL
No
Sponsors
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Acerta Pharma BV
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Research Site
Los Angeles, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
New York, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Houston, Texas, United States
Research Site
Leicester, , United Kingdom
Research Site
Plymouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2014-001341-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACE-LY-002
Identifier Type: -
Identifier Source: org_study_id