An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
3 other identifiers
interventional
124
10 countries
58
Brief Summary
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
Longer than P75 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedStudy Start
First participant enrolled
March 2, 2015
CompletedResults Posted
Study results publicly available
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2026
ExpectedFebruary 10, 2026
January 1, 2026
5.8 years
August 5, 2014
August 16, 2018
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.
The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.
From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days
Study Arms (1)
ACP-196 (acalabrutinib) Regimen 1
EXPERIMENTALACP-196 (acalabrutinib) Regimen 1
Interventions
Eligibility Criteria
You may qualify if:
- Men and women ≥ 18 years of age.
- 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.
You may not qualify if:
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at undue risk
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
Study Sites (58)
Research Site
Tampa, Florida, 33612, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Niles, Illinois, 60714, United States
Research Site
Peoria, Illinois, 61615, United States
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Boston, Massachusetts, 2215, United States
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Hackensack, New Jersey, 07601, United States
Research Site
New York, New York, 10021, United States
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Houston, Texas, 77030, United States
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Seattle, Washington, 98109, United States
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Monash, Australia
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Sydney, 2139, Australia
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Wodonga, 3690, Australia
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Bruges, 8000, Belgium
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Brussels, 1000, Belgium
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Brussels, 1200, Belgium
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Liège, 4000, Belgium
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Yvoir, 5530, Belgium
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Prague, 100 34, CZ, Czechia
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Angers, 49033, France
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Caen, 14033, France
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Clermond Ferrand, 63003, France
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Créteil, 94010, France
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Dijon, 21000, France
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Grenoble, 38043, France
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La Roche - Sure-Yon, 85925, France
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Lille, 59000, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Paris, 75015, France
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Paris, 75651, France
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Pessac, 33604, France
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Pierre-Bénite, 69310, France
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Rennes, 35033, France
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Rouen, 76038, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67098, France
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Toulouse, 31100, France
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Tours, 37000, France
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Vandœuvre-lès-Nancy, 54500, France
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Bologna, 40138, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Novara, 28100, Italy
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Amsterdam, 1105 AZ, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Rotterdam, 3062 PA, Netherlands
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Krakow, 30-727, Poland
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Lodz, 93-510, Poland
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Olsztyn, 10-228, Poland
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Badalona, 8916, Spain
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Pamplona, 31008, Spain
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Cardiff, CF14 4XW, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Leicester, LE1 7RH, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Oxford, 0X3 7LE, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
Research Site
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 29241979DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical -Study Information Center
Study Officials
- STUDY DIRECTOR
Acerta Pharma
1-888-292-9613
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2014
First Posted
August 12, 2014
Study Start
March 2, 2015
Primary Completion
December 4, 2020
Study Completion (Estimated)
September 9, 2026
Last Updated
February 10, 2026
Results First Posted
October 19, 2018
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.