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A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Primary Purpose

Lymphoma, Mantle Cell

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Acalabrutinib
Bendamustine
Rituximab
Placebo
Sponsored by
Acerta Pharma BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Mantle Cell focused on measuring Bruton tyrosine kinase inhibitor, Acalabrutinib, Mantle Cell Lymphoma, ACE-LY-308, Treatment naive, non-Hodgkins Lymphoma, Bendomustine, Rituximab

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 .

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acalabrutinib in combination with bendamustine and rituximab

Placebo in combination with bendamustine and rituximab

Arm Description

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.

Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Outcomes

Primary Outcome Measures

Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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.

Secondary Outcome Measures

Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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.
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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.
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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.
Overall survival in Arm 1 compared to Arm 2
Defined as the time from randomization until the date of death from any cause.
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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.
IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.

Full Information

First Posted
November 21, 2016
Last Updated
September 12, 2023
Sponsor
Acerta Pharma BV
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02972840
Brief Title
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
October 28, 2025 (Anticipated)
Study Completion Date
October 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Mantle Cell
Keywords
Bruton tyrosine kinase inhibitor, Acalabrutinib, Mantle Cell Lymphoma, ACE-LY-308, Treatment naive, non-Hodgkins Lymphoma, Bendomustine, Rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
635 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acalabrutinib in combination with bendamustine and rituximab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo in combination with bendamustine and rituximab
Arm Type
Placebo Comparator
Arm Description
Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
Intervention Type
Drug
Intervention Name(s)
Acalabrutinib
Other Intervention Name(s)
ACP-196, Calquence
Intervention Description
Administered orally (PO)
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda, Bendeka
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, Rituxan Hycela
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Description
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.
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Description
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.
Time Frame
Up to 6 years
Title
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Description
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.
Time Frame
Up to 6 years
Title
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Description
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.
Time Frame
Up to 6 years
Title
Overall survival in Arm 1 compared to Arm 2
Description
Defined as the time from randomization until the date of death from any cause.
Time Frame
Up to 6 years
Title
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Description
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.
Time Frame
Up to 6 years
Title
IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Description
Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 . 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.
Facility Information:
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Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
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United States
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Downey
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California
ZIP/Postal Code
90241
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United States
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Santa Monica
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California
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90404
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United States
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New Haven
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Connecticut
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06510
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United States
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Washington
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District of Columbia
ZIP/Postal Code
20007
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United States
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Tallahassee
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Florida
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32308-5304
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United States
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West Palm Beach
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Florida
ZIP/Postal Code
33401
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United States
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Research Site
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Marietta
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Georgia
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30060
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United States
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City
Westwood
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Kansas
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66205
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United States
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Louisville
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Kentucky
ZIP/Postal Code
40207
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United States
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Ann Arbor
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Michigan
ZIP/Postal Code
48109
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United States
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Rochester
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Minnesota
ZIP/Postal Code
55905-0001
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United States
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Kansas City
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Missouri
ZIP/Postal Code
64132
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United States
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Saint Louis
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Missouri
ZIP/Postal Code
63110
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United States
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Hackensack
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New Jersey
ZIP/Postal Code
07601
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United States
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Morristown
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New Jersey
ZIP/Postal Code
07960
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United States
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Hawthorne
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New York
ZIP/Postal Code
10532
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United States
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Lake Success
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New York
ZIP/Postal Code
11042
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United States
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Portland
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Oregon
ZIP/Postal Code
97239
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United States
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Charleston
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South Carolina
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29425
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United States
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Greenville
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South Carolina
ZIP/Postal Code
29615
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United States
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Chattanooga
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Tennessee
ZIP/Postal Code
37404
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United States
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Nashville
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Tennessee
ZIP/Postal Code
37203
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United States
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Houston
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Texas
ZIP/Postal Code
77030
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United States
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San Antonio
State/Province
Texas
ZIP/Postal Code
78217
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United States
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Tyler
State/Province
Texas
ZIP/Postal Code
75702
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United States
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Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
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United States
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Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
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United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
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City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
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United States
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City
Buenos Aires
ZIP/Postal Code
C1114AAP
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Argentina
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City
Buenos Aires
ZIP/Postal Code
C1426ANZ
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Argentina
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City
Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1431FWO
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Argentina
Facility Name
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City
Caba
ZIP/Postal Code
C1118AAT
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Argentina
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Cordoba
ZIP/Postal Code
5000
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Argentina
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Bedford Park
ZIP/Postal Code
5042
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Australia
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City
Concord
ZIP/Postal Code
2139
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Australia
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Frankston
ZIP/Postal Code
3199
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Australia
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Gosford
ZIP/Postal Code
2250
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Australia
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Heidelberg
ZIP/Postal Code
3084
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Australia
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Herston
ZIP/Postal Code
QLD, 4029
Country
Australia
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Research Site
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Kogarah
ZIP/Postal Code
NSW 2217
Country
Australia
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Murdoch
ZIP/Postal Code
6150
Country
Australia
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Nedlands
ZIP/Postal Code
6009
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Australia
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Newcastle
ZIP/Postal Code
2298
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Australia
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Southport
ZIP/Postal Code
4215
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Australia
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Sydney
ZIP/Postal Code
NSW 2145
Country
Australia
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Woolloongabba
ZIP/Postal Code
4102
Country
Australia
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Research Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Research Site
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
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City
Leuven
ZIP/Postal Code
3000
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Belgium
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City
Roeselare
ZIP/Postal Code
8900
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Belgium
Facility Name
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City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Research Site
City
Bela Vista
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
RS 90610-000
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01232-010
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05652-9000
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
1236030
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
5403
Country
Brazil
Facility Name
Research Site
City
So Paulo
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9,
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Site
City
Edmonton
ZIP/Postal Code
T6G 1Z2
Country
Canada
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Research Site
City
Greenfield Park
ZIP/Postal Code
J4V 2H1
Country
Canada
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City
Halifax
ZIP/Postal Code
NS B3H 2Y9
Country
Canada
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City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Research Site
City
Dalian
ZIP/Postal Code
116023
Country
China
Facility Name
Research Site
City
Gongshu District
ZIP/Postal Code
310022
Country
China
Facility Name
Research Site
City
Haidian District
ZIP/Postal Code
100191
Country
China
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330029
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Research Site
City
Qingdao
ZIP/Postal Code
266100
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Shenyang
Country
China
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215006
Country
China
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Research Site
City
Tianjian
ZIP/Postal Code
300020
Country
China
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Research Site
City
Tianjin
Country
China
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Research Site
City
Wuhou District
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Xicheng District
ZIP/Postal Code
100050
Country
China
Facility Name
Research Site
City
Xuhui District
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Facility Name
Research Site
City
Zhengzhou City
ZIP/Postal Code
450000
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05, CZ
Country
Czechia
Facility Name
Research Site
City
Ostrava Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Research Site
City
Pilsen
ZIP/Postal Code
30460, CZ
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
100 34, CZ
Country
Czechia
Facility Name
Research Site
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Research Site
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33076, FR
Country
France
Facility Name
Research Site
City
Le Mans
ZIP/Postal Code
72000, FR
Country
France
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site
City
Perigueux
ZIP/Postal Code
24019
Country
France
Facility Name
Research Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Rennes Cedex
ZIP/Postal Code
35000
Country
France
Facility Name
Research Site
City
Vienne
ZIP/Postal Code
86000, FR
Country
France
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120, DE
Country
Germany
Facility Name
Research Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Munchen
ZIP/Postal Code
81377, DE
Country
Germany
Facility Name
Research Site
City
Nordrhein-Westfalen
ZIP/Postal Code
52064, DE
Country
Germany
Facility Name
Research Site
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Research Site
City
Rheinland-Pfalz
ZIP/Postal Code
55131, DE
Country
Germany
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11525
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527, GR
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528, GR
Country
Greece
Facility Name
Research Site
City
Ioannina
ZIP/Postal Code
45500, GR
Country
Greece
Facility Name
Research Site
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54007, GR
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
57010, GR
Country
Greece
Facility Name
Research Site
City
HKG
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Research Site
City
Pok Fu Lam
Country
Hong Kong
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Research Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
494142
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Research Site
City
Parma
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Research Site
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Fukuoka City
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Research Site
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Research Site
City
Kyoto-city
ZIP/Postal Code
602-8026
Country
Japan
Facility Name
Research Site
City
Matsuyama-shi
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Research Site
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0006
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Research Site
City
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Research Site
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
7985
Country
Korea, Republic of
Facility Name
Research Site
City
MEX City
ZIP/Postal Code
2990
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Research Site
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Research Site
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Otahuhu
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Research Site
City
Arequipa
ZIP/Postal Code
5154
Country
Peru
Facility Name
Research Site
City
Bellavista
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Research Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Research Site
City
Woj. Podkarpackie
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
50012
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
070131
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Research Site
City
Pyatigorsk
ZIP/Postal Code
357532
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Syktyvkar
ZIP/Postal Code
167029
Country
Russian Federation
Facility Name
Research Site
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Research Site
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Research Site
City
Kiev
ZIP/Postal Code
3022
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Research Site
City
Zhytomir
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
123
Country
Vietnam
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh City
ZIP/Postal Code
WARD 7
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

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