Trial Search Results
A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
This trial is studying an investigational drug called ACP-196 (acalabrutinib). The study drug, ACP-196 (acalabrutinib), is a type of drug that blocks proteins inside cells that help cells live and grow. It is possible that the study drug may kill the cancer cells or stop them from growing. The purposes of this study are to find out if the study drug will slow or stop CLL from getting worse and whether the study drug causes side effects.
Stanford is currently not accepting patients for this trial.
Acerta Pharma BV
- Drug: ACP-196 (acalabrutinib)
1. Men and women ≥ 18 years of age.
2. Prior diagnosis of CLL
3. Must have received ≥ 1 prior therapy for CLL
4. Intolerant of ibrutinib
5. Documented disease progression after stopping ibrutinib therapy as defined by the
IWCLL 2008 criteria
6. Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty.
7. ECOG performance status of ≤ 2.
1. Ongoing AE attributed to ibrutinib therapy
2. Treatment with systemic anticancer therapy for CLL is prohibited between
discontinuation of ibrutinib and enrollment on this trial.
3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
4. 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 ≥ 2 years.
5. 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.
6. 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.
7. Evidence of active Richter's transformation or any evidence of disease progression on
ibrutinib therapy or any BTK inhibitor.
8. CNS involvement by CLL or related Richter's transformation.
9. Known history of human immunodeficiency virus (HIV), serologic status reflecting
active hepatitis B or C infection, or any uncontrolled active systemic infection.
10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura
11. History of stroke or intracranial hemorrhage within 2 months before the first dose of
12. History of bleeding diathesis.
13. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before
14. Major surgical procedure within 28 days of first dose of study drug.
15. Requires treatment with a strong CYP3A inhibitor
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study