Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Completed · Phase 1
Conditions studied: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
In brief
To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
Key facts
- Study ID
- NCT02112526
- Run by
- Acerta Pharma BV
- People needed
- 21
- Starts
- 2014-08-07
- Expected to finish
- 2024-10-04
- Last updated by the study team
- 2024-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women ≥ 18 years of age.
- Pathologically confirmed de novo ABC DLBCL
- Relapsed or refractory disease
- Subjects must have ≥ 1 measurable disease sites
You may not qualify if…
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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