An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
NCT ID: NCT02213926
Last Updated: 2025-11-25
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
124 participants
INTERVENTIONAL
2015-03-02
2026-09-06
Brief Summary
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Detailed Description
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Treatment with acalabrutinib may be continued until disease progression or an unacceptable drug-related toxicity occurs. Dose modification provisions are provided in the study protocol.
All subjects will have hematology, chemistry, and urinalysis safety panels done at screening. Once dosing commences (Day 1), all subjects will be evaluated for safety, including serum chemistry and hematology, once weekly for the first 4 weeks, every 2 weeks in Cycle 2, every 4 weeks in Cycles 3 to 12, and every 24 weeks thereafter. PK/PD testing will be done in Cycles 1 and 2. Tumor assessments will be completed at 8- to 24-week intervals during the trial.
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) Regimen 1
ACP-196 (acalabrutinib) Regimen 1
ACP-196 (acalabrutinib)
Interventions
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ACP-196 (acalabrutinib)
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Exclusion Criteria
* Significant cardiovascular disease such as uncontrolled or symptomatic 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 corrected QT interval (QTc) \> 480 msec.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant
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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Acerta Pharma
Role: STUDY_DIRECTOR
1-888-292-9613
Locations
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Research Site
Tampa, Florida, United States
Research Site
Chicago, Illinois, United States
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Niles, Illinois, United States
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Peoria, Illinois, United States
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Boston, Massachusetts, United States
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Hackensack, New Jersey, United States
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New York, New York, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Monash, , Australia
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Sydney, , Australia
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Wodonga, , Australia
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Bruges, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Yvoir, , Belgium
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Prague, , Czechia
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Angers, , France
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Caen, , France
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Clermond Ferrand, , France
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Créteil, , France
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Dijon, , France
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Grenoble, , France
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La Roche - Sure-Yon, , France
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Lille, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Pierre-Bénite, , France
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Rennes, , France
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Rouen, , France
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Saint-Priest-en-Jarez, , France
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Strasbourg, , France
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Toulouse, , France
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Tours, , France
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Vandœuvre-lès-Nancy, , France
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Bologna, , Italy
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Meldola, , Italy
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Milan, , Italy
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Novara, , Italy
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Amsterdam, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Badalona, , Spain
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Pamplona, , Spain
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Cardiff, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Plymouth, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.
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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2023-509352-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-002117-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACE-LY-004
Identifier Type: -
Identifier Source: org_study_id
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