A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Trial ID or NCT#

NCT02717611

Status

not recruiting iconNOT RECRUITING

Purpose

A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Official Title

A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Men and women ≥ 18 years of age.2. Prior diagnosis of CLL3. Must have received ≥ 1 prior therapy for CLL4. Intolerant of ibrutinib5. Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria6. 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.
Exclusion Criteria:
  1. 1. Ongoing AE attributed to ibrutinib therapy2. 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 (ITP)11. History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.12. History of bleeding diathesis.13. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.14. Major surgical procedure within 28 days of first dose of study drug.15. Requires treatment with a strong CYP3A inhibitor

Investigator(s)

David Iberri
David Iberri
Hematologist-Oncologist
Clinical Assistant Professor, Medicine - Hematology
Rondeep Brar
Rondeep Brar
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology

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Contact

Cancer Clinical Trials Office
650-498-7061