A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
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
3 other identifiers
interventional
635
27 countries
228
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2017
Longer than P75 for phase_3
228 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
February 18, 2026
February 1, 2026
9.9 years
November 21, 2016
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 6 years
Secondary Outcomes (6)
Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Up to 6 years
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Up to 6 years
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Up to 6 years
Overall survival in Arm 1 compared to Arm 2
Up to 6 years
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Up to 6 years
- +1 more secondary outcomes
Study Arms (2)
Acalabrutinib in combination with bendamustine and rituximab
EXPERIMENTALAcalabrutinib 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 in combination with bendamustine and rituximab
PLACEBO COMPARATORMatching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
Interventions
Administered orally (PO)
Administered intravenously (IV)
Administered intravenously (IV)
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
- AstraZenecacollaborator
Study Sites (228)
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Tucson, Arizona, 85719, United States
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Downey, California, 90241, United States
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Santa Monica, California, 90404, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Tallahassee, Florida, 32308-5304, United States
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West Palm Beach, Florida, 33401, United States
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Marietta, Georgia, 30060, United States
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Westwood, Kansas, 66205, United States
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Louisville, Kentucky, 40207, United States
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Ann Arbor, Michigan, 48109, United States
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Rochester, Minnesota, 55905-0001, United States
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Kansas City, Missouri, 64132, United States
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St Louis, Missouri, 63110, United States
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Hackensack, New Jersey, 07601, United States
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Morristown, New Jersey, 07960, United States
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Hawthorne, New York, 10532, United States
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Lake Success, New York, 11042, United States
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Portland, Oregon, 97239, United States
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Charleston, South Carolina, 29425, United States
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Greenville, South Carolina, 29615, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78217, United States
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Tyler, Texas, 75702, United States
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Charlottesville, Virginia, 22908, United States
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Fort Belvoir, Virginia, 22060, United States
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Seattle, Washington, 98108, United States
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Seattle, Washington, 98109, United States
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Seattle, Washington, 98122, United States
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Morgantown, West Virginia, 26506, United States
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Buenos Aires, C1114AAP, Argentina
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Buenos Aires, C1426ANZ, Argentina
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Buenos Aires, C1430EGF, Argentina
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Buenos Aires, C1431FWO, Argentina
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Caba, C1118AAT, Argentina
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CĂ³rdoba, 5000, Argentina
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Bedford Park, 5042, Australia
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Concord, 2139, Australia
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Frankston, 3199, Australia
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Gosford, 2250, Australia
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Heidelberg, 3084, Australia
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Herston, QLD, 4029, Australia
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Kogarah, NSW 2217, Australia
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Murdoch, 6150, Australia
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Nedlands, 6009, Australia
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Newcastle, 2298, Australia
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Southport, 4215, Australia
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Sydney, NSW 2145, Australia
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Woolloongabba, 4102, Australia
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Antwerp, 2060, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Roeselare, 8900, Belgium
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Sint-Niklaas, 9100, Belgium
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Bela Vista, 01321-001, Brazil
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Curitiba, 81520-060, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, RS 90610-000, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Salvador, 41253-190, Brazil
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SĂ£o Paulo, 01232-010, Brazil
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SĂ£o Paulo, 05652-9000, Brazil
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SĂ£o Paulo, 1236030, Brazil
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SĂ£o Paulo, 5403, Brazil
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So Paulo, 08270-070, Brazil
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Vancouver, British Columbia, V5Z 4E6, Canada
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Oshawa, Ontario, L1G 2B9,, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Edmonton, T6G 1Z2, Canada
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Greenfield Park, J4V 2H1, Canada
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Halifax, NS B3H 2Y9, Canada
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Beijing, 100036, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chongqing, 400037, China
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Dalian, 116023, China
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Gongshu District, 310022, China
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Haidian District, 100191, China
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Harbin, 150081, China
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Nanchang, 330006, China
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Nanchang, 330029, China
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Nanjing, 210029, China
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Qingdao, 266100, China
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Shanghai, China
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Shenyang, China
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Suzhou, 215006, China
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Tianjian, 300020, China
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Tianjin, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Wuhan, 430079, China
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Wuhou District, 610041, China
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Xicheng District, 100050, China
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Xuhui District, 200032, China
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Xuzhou, 221000, China
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Zhengzhou, 450000, China
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Zhengzhou, 450008, China
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Brno, 625 00, Czechia
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Hradec KrĂ¡lovĂ©, 500 05, CZ, Czechia
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Ostrava Poruba, 708 52, Czechia
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Pilsen, 30460, CZ, Czechia
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Prague, 100 34, CZ, Czechia
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Argenteuil, 95100, France
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Bobigny, 93000, France
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Bordeaux, 33076, FR, France
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Le Mans, 72000, FR, France
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Limoges, 87042, France
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Pessac, 33604, France
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PĂ©rigueux, 24019, France
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Rennes, 35000, France
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Vienne, 86000, FR, France
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Heidelberg, 69120, DE, Germany
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MĂ¼nchen, 81377, DE, Germany
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MĂ¼nster, 48149, Germany
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Nordrhein-Westfalen, 52064, DE, Germany
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Ravensburg, 88212, Germany
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Rheinland-Pfalz, 55131, DE, Germany
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Ulm, 89081, Germany
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Athens, 11525, Greece
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Athens, 11527, GR, Greece
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Athens, 11528, GR, Greece
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Ioannina, 45500, GR, Greece
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PĂ¡trai, 26504, Greece
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Thessaloniki, 54007, GR, Greece
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Thessaloniki, 57010, GR, Greece
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Hong Kong, 999077, Hong Kong
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Pok Fu Lam, Hong Kong
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Budapest, 1085, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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PĂ©cs, 7624, Hungary
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Szeged, 6725, Hungary
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Haifa, 31096, Israel
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Jerusalem, 9103102, Israel
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Petah Tikva, 494142, Israel
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Tel Aviv, 64239, Israel
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20162, Italy
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Palermo, 90146, Italy
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Parma, Italy
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Pavia, 27100, Italy
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Reggio Emilia, 42123, Italy
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Rozzano, 20089, Italy
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Turin, 10126, Italy
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Fukuoka, 811-1395, Japan
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Fukuoka, 812-8582, Japan
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Kobe, 650-0047, Japan
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Kyoto, 602-8026, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 460-0001, Japan
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Nagoya, 464-8681, Japan
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Osaka, 565-0871, Japan
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Sapporo, 003-0006, Japan
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Sendai, 980-8574, Japan
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Shimane, 693-8501, Japan
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Tokyo, 104-0045, Japan
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Tokyo, 135-8550, Japan
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Yokohama, 241-8515, Japan
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Mexico City, 2990, Mexico
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MĂ©xico, 14080, Mexico
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Monterrey, Mexico
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Querétaro, 76090, Mexico
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Dunedin, 9016, New Zealand
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Grafton, 1023, New Zealand
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Otahuhu, 1640, New Zealand
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Arequipa, 5154, Peru
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Bellavista, Peru
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Lima, 1, Peru
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Lima, 34, Peru
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ChorzĂ³w, 41-500, Poland
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Krakow, 30-510, Poland
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Lodz, 93-510, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-228, Poland
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Warsaw, 02-106, Poland
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Warsaw, 02-776, Poland
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Warsaw, 04-141, Poland
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Woj. Podkarpackie, 36-200, Poland
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Wroclaw, 50-367, Poland
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Brasov, 50012, Romania
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Bucharest, 070131, Romania
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Cluj-Napoca, 400124, Romania
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Iași, 700483, Romania
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Pyatigorsk, 357532, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197341, Russia
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Saint Petersburg, Russia
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Syktyvkar, 167029, Russia
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Tula, 300053, Russia
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Busan, 49201, South Korea
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Gyeonggi-do, 13620, South Korea
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Seoul, 3080, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Seoul, 6351, South Korea
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Seoul, 6591, South Korea
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Seoul, 7985, South Korea
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Badalona, 8916, Spain
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Barcelona, 08041, Spain
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Barcelona, 8003, Spain
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Barcelona, 8035, Spain
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Barcelona, 8907, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28046, Spain
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Majadahonda, 28222, Spain
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Pamplona, 31008, Spain
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Seville, Spain
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Valencia, 46026, Spain
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Kaohsiung City, 833, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 100, Taiwan
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Taoyuan District, 333, Taiwan
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Cherkasy, 18009, Ukraine
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Chernihiv, 14029, Ukraine
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Dnipropetrovsk, 49102, Ukraine
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Kiev, 3022, Ukraine
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Lviv, 79044, Ukraine
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Zhytomyr, 10002, Ukraine
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Hanoi, 123, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, WARD 7, Vietnam
Related Publications (1)
Wang M, Salek D, Belada D, Song Y, Jurczak W, Kahl BS, Paludo J, Chu MP, Kryachok I, Fogliatto L, Cheah CY, Morawska M, Sancho JM, Li Y, Patti C, Forsyth C, Zhang J, Lesley R, Ramadan S, Rule S, Dreyling M; ECHO investigators; ECHO Investigators. Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma. J Clin Oncol. 2025 Jul 10;43(20):2276-2284. doi: 10.1200/JCO-25-00690. Epub 2025 May 1.
PMID: 40311141DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2016
First Posted
November 25, 2016
Study Start
April 5, 2017
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
February 15, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.