Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL
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ClinicalTrials.gov Identifier: NCT02477696 |
Recruitment Status :
Active, not recruiting
First Posted : June 23, 2015
Results First Posted : January 28, 2022
Last Update Posted : June 16, 2022
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Sponsor:
Acerta Pharma BV
Information provided by (Responsible Party):
Acerta Pharma BV
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | June 12, 2015 | ||||||||||||||
First Posted Date ICMJE | June 23, 2015 | ||||||||||||||
Results First Submitted Date ICMJE | September 10, 2021 | ||||||||||||||
Results First Posted Date ICMJE | January 28, 2022 | ||||||||||||||
Last Update Posted Date | June 16, 2022 | ||||||||||||||
Actual Study Start Date ICMJE | July 28, 2015 | ||||||||||||||
Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment [ Time Frame: Randomization to Disease Progression, Death, or Censoring. Assessed for up to 5 years at the time of analysis. ] The time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause. Progression by IRC is defined per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria as lymphocyte count >/= 50% from baseline; >/= 50% increase in lymph nodes, liver or spleen; >/= 50% decrease in platelets from baseline or decrease in hemoglobin > 2 g/dL from baseline and related to CLL.
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Original Primary Outcome Measures ICMJE |
Progression-free survival in Arm A compared to Arm B [ Time Frame: 36 months ] | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
Number of Patients With Atrial Fibrillation [ Time Frame: Date of first dose until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first). Median follow-up was 41 months. ] Includes MedDRA preferred terms 'atrial fibrillation' and 'atrial flutter'.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL | ||||||||||||||
Official Title ICMJE | A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia | ||||||||||||||
Brief Summary | This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia. | ||||||||||||||
Detailed Description | Not Provided | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Lymphocytic Leukemia | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
533 | ||||||||||||||
Original Estimated Enrollment ICMJE |
500 | ||||||||||||||
Estimated Study Completion Date ICMJE | August 31, 2027 | ||||||||||||||
Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Spain, Turkey, United Kingdom, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT02477696 | ||||||||||||||
Other Study ID Numbers ICMJE | ACE-CL-006 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Acerta Pharma BV | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Acerta Pharma BV | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Acerta Pharma BV | ||||||||||||||
Verification Date | May 2022 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |