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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
Date last updated
18/06/2024
Titles & IDs
Public title
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
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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
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Secondary ID [1]
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2015-005220-26
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Secondary ID [2]
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ACE-LY-308
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Mantle Cell
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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Assessment method [1]
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Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
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Timepoint [1]
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Up to 6 years
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Secondary outcome [1]
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Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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Assessment method [1]
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Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
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Timepoint [1]
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Up to 6 years
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Secondary outcome [2]
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Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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Assessment method [2]
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Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.
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Timepoint [2]
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Up to 6 years
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Secondary outcome [3]
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IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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Assessment method [3]
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Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.
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Timepoint [3]
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Up to 6 years
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Secondary outcome [4]
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Overall survival in Arm 1 compared to Arm 2
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Assessment method [4]
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Defined as the time from randomization until the date of death from any cause.
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Timepoint [4]
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Up to 6 years
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Secondary outcome [5]
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IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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Assessment method [5]
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Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.
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Timepoint [5]
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Up to 6 years
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Secondary outcome [6]
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IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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Assessment method [6]
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Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.
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Timepoint [6]
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Up to 6 years
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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 .
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
635
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Bedford Park
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Research Site - Concord
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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2139 - Concord
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3199 - Frankston
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2250 - Gosford
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3084 - Heidelberg
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QLD, 4029 - Herston
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NSW 2217 - Kogarah
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6150 - Murdoch
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6009 - Nedlands
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2298 - Newcastle
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4215 - Southport
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NSW 2145 - Sydney
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4102 - Woolloongabba
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Recruitment outside Australia
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Matsuyama-shi
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Country [114]
0
0
Japan
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State/province [114]
0
0
Nagoya-shi
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Country [115]
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0
Japan
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State/province [115]
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0
Nagoya
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Country [116]
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0
Japan
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State/province [116]
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Osaka
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Country [117]
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0
Japan
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State/province [117]
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0
Sapporo-shi
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Country [118]
0
0
Japan
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State/province [118]
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0
Sendai-shi
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Country [119]
0
0
Japan
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State/province [119]
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Shimane
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Country [120]
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0
Japan
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Tokyo
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Country [121]
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0
Japan
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Yokohama-shi
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Country [122]
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Korea, Republic of
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Busan
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Country [123]
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Korea, Republic of
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Gyeonggi-do
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Country [124]
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Korea, Republic of
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Seoul
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Country [125]
0
0
Mexico
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MEX City
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Country [126]
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0
Mexico
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Mexico
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Country [127]
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Mexico
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Monterrey
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Country [128]
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Mexico
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Queretaro
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Country [129]
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New Zealand
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Dunedin
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New Zealand
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Grafton
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Country [131]
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New Zealand
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0
Otahuhu
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Country [132]
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0
Peru
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State/province [132]
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0
Arequipa
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Country [133]
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Peru
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State/province [133]
0
0
Bellavista
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Country [134]
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0
Peru
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0
0
Lima
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Country [135]
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0
Poland
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Chorzow
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Country [136]
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0
Poland
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State/province [136]
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Krakow
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Country [137]
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Poland
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State/province [137]
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Lodz
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Country [138]
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Poland
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Lublin
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Country [139]
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Poland
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State/province [139]
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Olsztyn
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Country [140]
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Poland
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State/province [140]
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Warszawa
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Country [141]
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0
Poland
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State/province [141]
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Woj. Podkarpackie
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Country [142]
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0
Poland
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State/province [142]
0
0
Wroclaw
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Country [143]
0
0
Romania
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State/province [143]
0
0
Brasov
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Country [144]
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0
Romania
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State/province [144]
0
0
Bucharest
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Country [145]
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0
Romania
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State/province [145]
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0
Cluj-Napoca
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Country [146]
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Romania
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State/province [146]
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Iasi
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Country [147]
0
0
Russian Federation
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State/province [147]
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0
Pyatigorsk
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Country [148]
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0
Russian Federation
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State/province [148]
0
0
Saint Petersburg
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Country [149]
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0
Russian Federation
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State/province [149]
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0
St. Petersburg
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Country [150]
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Russian Federation
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State/province [150]
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0
Syktyvkar
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Country [151]
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0
Russian Federation
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State/province [151]
0
0
Tula
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Country [152]
0
0
Spain
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State/province [152]
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0
Badalona
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Country [153]
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0
Spain
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State/province [153]
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0
Barcelona
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Country [154]
0
0
Spain
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State/province [154]
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Madrid
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Country [155]
0
0
Spain
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State/province [155]
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0
Majadahonda
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Country [156]
0
0
Spain
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State/province [156]
0
0
Pamplona
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Country [157]
0
0
Spain
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State/province [157]
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0
Sevilla
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Country [158]
0
0
Spain
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State/province [158]
0
0
Valencia
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Country [159]
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0
Taiwan
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State/province [159]
0
0
Kaohsiung
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Country [160]
0
0
Taiwan
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State/province [160]
0
0
Taichung
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Country [161]
0
0
Taiwan
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State/province [161]
0
0
Taipei
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Country [162]
0
0
Taiwan
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State/province [162]
0
0
Taoyuan
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Country [163]
0
0
Ukraine
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State/province [163]
0
0
Cherkasy
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Country [164]
0
0
Ukraine
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State/province [164]
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0
Chernihiv
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Country [165]
0
0
Ukraine
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State/province [165]
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0
Dnipropetrovsk
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Country [166]
0
0
Ukraine
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State/province [166]
0
0
Kiev
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Country [167]
0
0
Ukraine
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State/province [167]
0
0
Lviv
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Country [168]
0
0
Ukraine
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State/province [168]
0
0
Zhytomir
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Country [169]
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0
Vietnam
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State/province [169]
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0
Hanoi
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Country [170]
0
0
Vietnam
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State/province [170]
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0
Ho Chi Minh City
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Country [171]
0
0
Vietnam
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State/province [171]
0
0
Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Acerta Pharma BV
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
AstraZeneca
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
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Trial website
https://clinicaltrials.gov/study/NCT02972840
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT02972840
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