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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02972840




Registration number
NCT02972840
Ethics application status
Date submitted
21/11/2016
Date registered
25/11/2016

Titles & IDs
Public title
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma
Secondary ID [1] 0 0
2015-005220-26
Secondary ID [2] 0 0
ACE-LY-308
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Mantle Cell 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
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Placebo

Experimental: Acalabrutinib in combination with bendamustine and rituximab - Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Placebo comparator: Placebo in combination with bendamustine and rituximab - Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.


Treatment: Drugs: Acalabrutinib
Administered orally (PO)

Treatment: Drugs: Bendamustine
Administered intravenously (IV)

Treatment: Drugs: Rituximab
Administered intravenously (IV)

Treatment: Drugs: Placebo
Placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [1] 0 0
Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [3] 0 0
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Timepoint [3] 0 0
Up to 6 years
Secondary outcome [4] 0 0
Overall survival in Arm 1 compared to Arm 2
Timepoint [4] 0 0
Up to 6 years
Secondary outcome [5] 0 0
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Timepoint [5] 0 0
Up to 6 years
Secondary outcome [6] 0 0
IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Timepoint [6] 0 0
Up to 6 years

Eligibility
Key inclusion criteria
* Men and women, = 65 years of age.
* Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) .
* MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
* Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
* Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, 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 (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
* Concurrent participation in another therapeutic clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
5/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2025
Actual
Sample size
Target
Accrual to date
Final
635
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Frankston
Recruitment hospital [4] 0 0
Research Site - Gosford
Recruitment hospital [5] 0 0
Research Site - Heidelberg
Recruitment hospital [6] 0 0
Research Site - Herston
Recruitment hospital [7] 0 0
Research Site - Kogarah
Recruitment hospital [8] 0 0
Research Site - Murdoch
Recruitment hospital [9] 0 0
Research Site - Nedlands
Recruitment hospital [10] 0 0
Research Site - Newcastle
Recruitment hospital [11] 0 0
Research Site - Southport
Recruitment hospital [12] 0 0
Research Site - Sydney
Recruitment hospital [13] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
QLD, 4029 - Herston
Recruitment postcode(s) [7] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
2298 - Newcastle
Recruitment postcode(s) [11] 0 0
4215 - Southport
Recruitment postcode(s) [12] 0 0
NSW 2145 - Sydney
Recruitment postcode(s) [13] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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New York
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Washington
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West Virginia
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Argentina
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Buenos Aires
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Prague
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Pavia
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Fukuoka
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Nagoya
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Osaka
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Shimane
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Japan
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Tokyo
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Japan
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Korea, Republic of
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Busan
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Gyeonggi-do
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Seoul
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Wroclaw
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Brasov
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Cluj-Napoca
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Iasi
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Syktyvkar
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Tula
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Barcelona
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Madrid
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Sevilla
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Valencia
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Kaohsiung
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Zhytomir
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Hanoi
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Ho Chi Minh City
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acerta Pharma BV
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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 de-identified 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 athttps://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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02972840