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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

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
2014-002117-28
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
130 Years
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
NA
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
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Belgium
State/province [8] 0 0
Brugge
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
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
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France
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Lille
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France
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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
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Rouen
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France
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St Priest en Jarez
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France
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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
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Vandoeuvre-les-Nancy
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Italy
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Bologna
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Italy
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Meldola
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Italy
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Milano
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Italy
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Novara
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Netherlands
State/province [38] 0 0
Amsterdam
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Netherlands
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Maastricht
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Netherlands
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Rotterdam
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Poland
State/province [41] 0 0
Kraków
Country [42] 0 0
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
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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
Country [51] 0 0
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02213926