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

Running, not enrolling · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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

Key facts

Study ID

NCT02717611

Run by

Acerta Pharma BV

People needed

60

Starts

2016-03-08

Expected to finish

2026-06-06

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age.
• Prior diagnosis of CLL
• Must have received ≥ 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 ≤ 2.

You may not qualify if…

• 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 ≥ 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

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Concord, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Lake Success, New York, United States
• Research Site — New York, New York, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Sherman, Texas, United States
• Research Site — Seattle, Washington, United States
• Research Site — Seattle, Washington, United States
• Research Site — Spokane, Washington, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Bruges, Belgium
• Research Site — Bordeaux, France
• Research Site — Haifa, Israel
• Research Site — Madrid, Spain
• Research Site — Bournemouth, United Kingdom
• Research Site — Leeds, United Kingdom
• Research Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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