A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
NCT ID: NCT02717611
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2016-03-08
2026-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ACP-196 (acalabrutinib)
ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID
ACP-196 (acalabrutinib)
ACP-196 100 mg to be administered orally (PO) twice a day BID.
Interventions
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ACP-196 (acalabrutinib)
ACP-196 100 mg to be administered orally (PO) twice a day BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Acerta Pharma BV
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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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
Countries
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References
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Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.
Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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ACE-CL-208
Identifier Type: -
Identifier Source: org_study_id
2015-005317-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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