ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (Btk) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia
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This study is evaluating the safety and efficacy of a new Bruton tyrosine kinase (Btk) inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL, which has relapsed after, or been refractory to, ≥ 2 previous treatments for CLL/SLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL/SLL.
Treatment Naive only: and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy.
Richter's Syndrome and Prolymphocytic Leukemia Transformation only: biopsy proven DLBCL Richter's transformation or prolymphocytic leukemia transformation.
Subjects have been diagnosed with measurable CLL/SLL.
Subjects have active disease meeting the IWCLL 2008 published criteria.
ECOG performance status of ≤ 2.
Agreement to use contraception during the study and for 90 days after the last dose of study drug if sexually active and able to bear children.
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years. Note: these cases must be discussed with the Medical Monitor.
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 left ventricular ejection fraction (LVEF) ≤ 40%.
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.
Any immunotherapy within 4 weeks of first dose of study drug.
For subjects with recent chemotherapy or experimental therapy the first dose of study drug must occur after 5 times the half-life of the agent(s).
Relapsed after, or refractory to, prior BTK inhibitor therapy.
Central nervous system (CNS) involvement by lymphoma
Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation.
Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or any uncontrolled active systemic infection.
Major surgery within 4 weeks before first dose of study drug.
ANC < 0.75 x 109/L or platelet count < 50 x 109/L unless there is bone marrow involvement.
Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN unless disease related.
Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN.
Significant screening ECG abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, and QTc ≥ 480 ms.
Cardiac troponin I or cardiac troponin T levels above the limit of normal as specified by the manufacturer.