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Active, not recruiting Phase 2

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

NCT02717611 · tracked via the Priya Life Science UK tracker
Phase
Phase 2
Started
2016-03-08
Last updated
2026-03-25

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

ACP-196 (acalabrutinib) →

ACP-196 (acalabrutinib): ACP-196 100 mg to be administered orally (PO) twice a day BID.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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. Exclusion Criteria: 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 (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

Primary outcome measure(s)

  • The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) — From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 4 years and 7 months). 1 cycle = 28 days
    The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy. ORR is defined as the proportion of subjects achieving a best overall response (BOR) of either complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) at or before initiation of subsequent anticancer therapy. ORR will be analyzed per investigator's assessment.

Trial sites (23)

FacilityCityRegionStatus
Research Site Tucson Arizona
Research Site Concord California
Research Site La Jolla California
Research Site Palo Alto California
Research Site Washington D.C. District of Columbia
Research Site Chicago Illinois
Research Site Lake Success New York
Research Site New York New York
Research Site Columbus Ohio
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site Sherman Texas
Research Site Seattle Washington
Research Site Seattle Washington
Research Site Spokane Washington
Research Site Milwaukee Wisconsin
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02717611 on ClinicalTrials.gov ↗ ← All trials in the UK