Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
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Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL. [ Time Frame: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose. ]
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Secondary Outcome Measures :
Area Under the Plasma Concentration (AUC) [ Time Frame: 1 Cycle (28 days) ]
To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 1 Cycle (28 days) ]
To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only) [ Time Frame: 2 Cycles (1 cycle = 28 days) and at end of treatment ]
To evaluate the concentration pharmacodynamic effects of acalabrutinib
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR) [ Time Frame: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days) ]
To evaluate the activity of acalabrutinib as measured by ORR
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Ages Eligible for Study:
18 Years to 130 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women ≥ 18 years of age.
Pathologically confirmed de novo ABC DLBCL
Relapsed or refractory disease
Subjects must have ≥ 1 measurable disease sites
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Keywords provided by Acerta Pharma BV:
de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
de Novo Activated B-cell (ABC)
de Novo Activated B-cell
Immune System Diseases
Bruton's tyrosine kinase
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type