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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02213926




Registration number
NCT02213926
Ethics application status
Date submitted
5/08/2014
Date registered
12/08/2014
Date last updated
27/11/2024

Titles & IDs
Public title
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
Scientific title
An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
Secondary ID [1] 0 0
2023-509352-34-00
Secondary ID [2] 0 0
ACE-LY-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mantle Cell Lymphoma (MCL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: ACP-196 (acalabrutinib) Regimen 1 - ACP-196 (acalabrutinib) Regimen 1
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.
Timepoint [1] 0 0
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

Eligibility
Key inclusion criteria
Inclusion criteria:

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/09/2026
Actual
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Monash
Recruitment hospital [2] 0 0
Research Site - Sydney
Recruitment hospital [3] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
- Monash
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
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United States of America
State/province [2] 0 0
Illinois
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United States of America
State/province [3] 0 0
Massachusetts
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Texas
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United States of America
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Washington
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Liège
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Belgium
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Yvoir
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Czechia
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Prague
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France
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Angers
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France
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Caen
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France
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Clermond Ferrand
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France
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Creteil
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France
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Dijon
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France
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Grenoble Cedex 09
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France
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La Roche - Sure-Yon
Country [20] 0 0
France
State/province [20] 0 0
Lille
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France
State/province [21] 0 0
Montpellier
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France
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Nantes
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France
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Paris cedex 13
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France
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Paris
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France
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Pessac
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France
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Pierre-Benite
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France
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Rennes
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France
State/province [28] 0 0
Rouen
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France
State/province [29] 0 0
Saint-Priest-En-Jarez
Country [30] 0 0
France
State/province [30] 0 0
Strasbourg Cedex
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France
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Toulouse
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France
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Tours
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France
State/province [33] 0 0
Vandoeuvre-les-Nancy
Country [34] 0 0
Italy
State/province [34] 0 0
Bologna
Country [35] 0 0
Italy
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Meldola
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Novara
Country [38] 0 0
Netherlands
State/province [38] 0 0
Amsterdam
Country [39] 0 0
Netherlands
State/province [39] 0 0
Maastricht
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Netherlands
State/province [40] 0 0
Rotterdam
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Poland
State/province [41] 0 0
Kraków
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Poland
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Lodz
Country [43] 0 0
Poland
State/province [43] 0 0
Olsztyn
Country [44] 0 0
Spain
State/province [44] 0 0
Badalona
Country [45] 0 0
Spain
State/province [45] 0 0
Pamplona
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Cardiff
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Leeds
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Leicester
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United Kingdom
State/province [49] 0 0
Nottingham
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United Kingdom
State/province [50] 0 0
Oxford
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United Kingdom
State/province [51] 0 0
Plymouth
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acerta Pharma BV
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02213926
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Acerta Pharma
Address 0 0
1-888-292-9613
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02213926