Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
2015-005220-26
Query!
Secondary ID [2]
0
0
ACE-LY-308
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Mantle Cell
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to 6 years
Query!
Secondary outcome [1]
0
0
Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to 6 years
Query!
Secondary outcome [2]
0
0
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to 6 years
Query!
Secondary outcome [3]
0
0
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to 6 years
Query!
Secondary outcome [4]
0
0
Overall survival in Arm 1 compared to Arm 2
Query!
Assessment method [4]
0
0
Defined as the time from randomization until the date of death from any cause.
Query!
Timepoint [4]
0
0
Up to 6 years
Query!
Secondary outcome [5]
0
0
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Up to 6 years
Query!
Secondary outcome [6]
0
0
IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Query!
Assessment method [6]
0
0
Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.
Query!
Timepoint [6]
0
0
Up to 6 years
Query!
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 .
Query!
Minimum age
65
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/04/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/10/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
635
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Bedford Park
Query!
Recruitment hospital [2]
0
0
Research Site - Concord
Query!
Recruitment hospital [3]
0
0
Research Site - Frankston
Query!
Recruitment hospital [4]
0
0
Research Site - Gosford
Query!
Recruitment hospital [5]
0
0
Research Site - Heidelberg
Query!
Recruitment hospital [6]
0
0
Research Site - Herston
Query!
Recruitment hospital [7]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [8]
0
0
Research Site - Murdoch
Query!
Recruitment hospital [9]
0
0
Research Site - Nedlands
Query!
Recruitment hospital [10]
0
0
Research Site - Newcastle
Query!
Recruitment hospital [11]
0
0
Research Site - Southport
Query!
Recruitment hospital [12]
0
0
Research Site - Sydney
Query!
Recruitment hospital [13]
0
0
Research Site - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [3]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [4]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [5]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [6]
0
0
QLD, 4029 - Herston
Query!
Recruitment postcode(s) [7]
0
0
NSW 2217 - Kogarah
Query!
Recruitment postcode(s) [8]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [9]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [10]
0
0
2298 - Newcastle
Query!
Recruitment postcode(s) [11]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [12]
0
0
NSW 2145 - Sydney
Query!
Recruitment postcode(s) [13]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oregon
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
South Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Tennessee
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
West Virginia
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Caba
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Cordoba
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Antwerpen
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Ghent
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Leuven
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Roeselare
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Sint-Niklaas
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Bela Vista
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Curitiba
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Porto Alegre
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Rio de Janeiro
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Salvador
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Sao Paulo
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
So Paulo
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
British Columbia
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Ontario
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Edmonton
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Greenfield Park
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Halifax
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Beijing
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Changchun
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Changsha
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Chongqing
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Dalian
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Gongshu District
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Haidian District
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Harbin
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Nanchang
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Nanjing
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Qingdao
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Shanghai
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Shenyang
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Suzhou
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Tianjian
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Tianjin
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Wenzhou
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Wuhan
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Wuhou District
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Xicheng District
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Xuhui District
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Xuzhou
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Zhengzhou City
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Zhengzhou
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Brno
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Hradec Kralove
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Ostrava Poruba
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Pilsen
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Prague
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Argenteuil
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Bobigny
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Bordeaux
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Le Mans
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Limoges
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Perigueux
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Pessac
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Rennes Cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Vienne
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Heidelberg
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Muenster
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Munchen
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Nordrhein-Westfalen
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Ravensburg
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Rheinland-Pfalz
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Ulm
Query!
Country [86]
0
0
Greece
Query!
State/province [86]
0
0
Athens
Query!
Country [87]
0
0
Greece
Query!
State/province [87]
0
0
Ioannina
Query!
Country [88]
0
0
Greece
Query!
State/province [88]
0
0
Patras
Query!
Country [89]
0
0
Greece
Query!
State/province [89]
0
0
Thessaloniki
Query!
Country [90]
0
0
Hong Kong
Query!
State/province [90]
0
0
HKG
Query!
Country [91]
0
0
Hong Kong
Query!
State/province [91]
0
0
Pok Fu Lam
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Budapest
Query!
Country [93]
0
0
Hungary
Query!
State/province [93]
0
0
Debrecen
Query!
Country [94]
0
0
Hungary
Query!
State/province [94]
0
0
Gyor
Query!
Country [95]
0
0
Hungary
Query!
State/province [95]
0
0
Pecs
Query!
Country [96]
0
0
Hungary
Query!
State/province [96]
0
0
Szeged
Query!
Country [97]
0
0
Israel
Query!
State/province [97]
0
0
Haifa
Query!
Country [98]
0
0
Israel
Query!
State/province [98]
0
0
Jerusalem
Query!
Country [99]
0
0
Israel
Query!
State/province [99]
0
0
Petah Tikva
Query!
Country [100]
0
0
Israel
Query!
State/province [100]
0
0
Tel Aviv
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Bologna
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Milano
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Palermo
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
Parma
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
Pavia
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
Reggio Emilia
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
Rozzano
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
Turin
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Fukuoka City
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Fukuoka
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Kobe-shi
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kyoto-city
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Matsuyama-shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Nagoya-shi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Nagoya
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Osaka
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Sapporo-shi
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Sendai-shi
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Shimane
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Tokyo
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Yokohama-shi
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Busan
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Gyeonggi-do
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Seoul
Query!
Country [125]
0
0
Mexico
Query!
State/province [125]
0
0
MEX City
Query!
Country [126]
0
0
Mexico
Query!
State/province [126]
0
0
Mexico
Query!
Country [127]
0
0
Mexico
Query!
State/province [127]
0
0
Monterrey
Query!
Country [128]
0
0
Mexico
Query!
State/province [128]
0
0
Queretaro
Query!
Country [129]
0
0
New Zealand
Query!
State/province [129]
0
0
Dunedin
Query!
Country [130]
0
0
New Zealand
Query!
State/province [130]
0
0
Grafton
Query!
Country [131]
0
0
New Zealand
Query!
State/province [131]
0
0
Otahuhu
Query!
Country [132]
0
0
Peru
Query!
State/province [132]
0
0
Arequipa
Query!
Country [133]
0
0
Peru
Query!
State/province [133]
0
0
Bellavista
Query!
Country [134]
0
0
Peru
Query!
State/province [134]
0
0
Lima
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Chorzow
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Krakow
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Lodz
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Lublin
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Olsztyn
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Warszawa
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Woj. Podkarpackie
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Wroclaw
Query!
Country [143]
0
0
Romania
Query!
State/province [143]
0
0
Brasov
Query!
Country [144]
0
0
Romania
Query!
State/province [144]
0
0
Bucharest
Query!
Country [145]
0
0
Romania
Query!
State/province [145]
0
0
Cluj-Napoca
Query!
Country [146]
0
0
Romania
Query!
State/province [146]
0
0
Iasi
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Pyatigorsk
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Saint Petersburg
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
St. Petersburg
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
Syktyvkar
Query!
Country [151]
0
0
Russian Federation
Query!
State/province [151]
0
0
Tula
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Badalona
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
Barcelona
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
Madrid
Query!
Country [155]
0
0
Spain
Query!
State/province [155]
0
0
Majadahonda
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
Pamplona
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Sevilla
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Valencia
Query!
Country [159]
0
0
Taiwan
Query!
State/province [159]
0
0
Kaohsiung
Query!
Country [160]
0
0
Taiwan
Query!
State/province [160]
0
0
Taichung
Query!
Country [161]
0
0
Taiwan
Query!
State/province [161]
0
0
Taipei
Query!
Country [162]
0
0
Taiwan
Query!
State/province [162]
0
0
Taoyuan
Query!
Country [163]
0
0
Ukraine
Query!
State/province [163]
0
0
Cherkasy
Query!
Country [164]
0
0
Ukraine
Query!
State/province [164]
0
0
Chernihiv
Query!
Country [165]
0
0
Ukraine
Query!
State/province [165]
0
0
Dnipropetrovsk
Query!
Country [166]
0
0
Ukraine
Query!
State/province [166]
0
0
Kiev
Query!
Country [167]
0
0
Ukraine
Query!
State/province [167]
0
0
Lviv
Query!
Country [168]
0
0
Ukraine
Query!
State/province [168]
0
0
Zhytomir
Query!
Country [169]
0
0
Vietnam
Query!
State/province [169]
0
0
Hanoi
Query!
Country [170]
0
0
Vietnam
Query!
State/province [170]
0
0
Ho Chi Minh City
Query!
Country [171]
0
0
Vietnam
Query!
State/province [171]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Acerta Pharma BV
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
AstraZeneca
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02972840
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
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