Chronic Lymphocytic Leukemia Clinical Trial
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.
Men and women â‰¥ 18 years of age.
Prior diagnosis of CLL
Must have received â‰¥ 1 prior therapy for CLL
Intolerant of ibrutinib
Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
ECOG performance status of â‰¤ 2.
Ongoing AE attributed to ibrutinib therapy
Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for â‰¥ 2 years.
Significant cardiovascular disease such as uncontrolled or symptomatic untreated 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 QTc > 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
CNS involvement by CLL or related Richter's transformation.
Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.
History of bleeding diathesis.
Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
Major surgical procedure within 28 days of first dose of study drug.
Requires treatment with a strong CYP3A inhibitor
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There are 23 Locations for this study
Tucson Arizona, 85704, United States
Concord California, 94520, United States
La Jolla California, 92093, United States
Palo Alto California, 94304, United States
Washington District of Columbia, 20007, United States
Chicago Illinois, 60611, United States
Lake Success New York, 11042, United States
New York New York, 10021, United States
Columbus Ohio, 43210, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Sherman Texas, USA, United States
Seattle Washington, 98108, United States
Seattle Washington, 98122, United States
Spokane Washington, 99208, United States
Milwaukee Wisconsin, 53226, United States
Brugge , 8000, Belgium
Bordeaux , 33076, France
Haifa , 31000, Israel
Madrid , 28006, Spain
Bournemouth , BH7 7, United Kingdom
Leeds , LS9 7, United Kingdom
Manchester , M20 4, United Kingdom
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