Lymphoma, Mantle CellPhase 3NCT02972840

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

A Phase 3 study testing Acalabrutinib, Bendamustine and Rituximab in people with Lymphoma, Mantle Cell, run by Acerta Pharma BV at 228 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Lymphoma, Mantle Cell
What is being tested?: Acalabrutinib, Bendamustine and Rituximab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 635 participants
Where: 228 sitesin 27 countries
Study dates: 5 Apr 2017to 15 Feb 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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 .

Who cannot join

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.

Trial locations and contacts

228 sites in 27 countries.

Country

City, postcode or hospital

228 sites in 27 countries

United States32 sites

Research Site
Ann Arbor, Michigan, 48109
Research Site
Charleston, South Carolina, 29425
Research Site
Charlottesville, Virginia, 22908
Research Site
Chattanooga, Tennessee, 37404
Research Site
Downey, California, 90241
Research Site
Fort Belvoir, Virginia, 22060
Research Site
Greenville, South Carolina, 29615
Research Site
Hackensack, New Jersey, 07601
Research Site
Hawthorne, New York, 10532
Research Site
Houston, Texas, 77030
Research Site
Kansas City, Missouri, 64132
Research Site
Lake Success, New York, 11042
Research Site
Louisville, Kentucky, 40207
Research Site
Marietta, Georgia, 30060
Research Site
Morgantown, West Virginia, 26506
Research Site
Morristown, New Jersey, 07960
Research Site
Nashville, Tennessee, 37203
Research Site
New Haven, Connecticut, 06510
Research Site
Portland, Oregon, 97239
Research Site
Rochester, Minnesota, 55905-0001
Research Site
San Antonio, Texas, 78217
Research Site
Santa Monica, California, 90404
Research Site
Seattle, Washington, 98108
Research Site
Seattle, Washington, 98109
Research Site
Seattle, Washington, 98122
Research Site
St Louis, Missouri, 63110
Research Site
Tallahassee, Florida, 32308-5304
Research Site
Tucson, Arizona, 85719
Research Site
Tyler, Texas, 75702
Research Site
Washington D.C., District of Columbia, 20007
Research Site
West Palm Beach, Florida, 33401
Research Site
Westwood, Kansas, 66205

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China27 sites

Research Site
Beijing, 100036
Research Site
Changchun, 130021
Research Site
Changsha, 410008
Research Site
Changsha, 410013
Research Site
Chongqing, 400037
Research Site
Dalian, 116023
Research Site
Gongshu District, 310022
Research Site
Haidian District, 100191
Research Site
Harbin, 150081
Research Site
Nanchang, 330006
Research Site
Nanchang, 330029
Research Site
Nanjing, 210029
Research Site
Qingdao, 266100
Research Site
Shanghai
Research Site
Shenyang
Research Site
Suzhou, 215006
Research Site
Tianjian, 300020
Research Site
Tianjin
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430030
Research Site
Wuhan, 430079
Research Site
Wuhou District, 610041
Research Site
Xicheng District, 100050
Research Site
Xuhui District, 200032
Research Site
Xuzhou, 221000
Research Site
Zhengzhou, 450000
Research Site
Zhengzhou, 450008

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Japan14 sites

Research Site
Fukuoka, 811-1395
Research Site
Fukuoka, 812-8582
Research Site
Kobe, 650-0047
Research Site
Kyoto, 602-8026
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 460-0001
Research Site
Nagoya, 464-8681
Research Site
Osaka, 565-0871
Research Site
Sapporo, 003-0006
Research Site
Sendai, 980-8574
Research Site
Shimane, 693-8501
Research Site
Tokyo, 104-0045
Research Site
Tokyo, 135-8550
Research Site
Yokohama, 241-8515

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Australia13 sites

Research Site
Bedford Park, 5042
Research Site
Concord, 2139
Research Site
Frankston, 3199
Research Site
Gosford, 2250
Research Site
Heidelberg, 3084
Research Site
Herston, QLD, 4029
Research Site
Kogarah, NSW 2217
Research Site
Murdoch, 6150
Research Site
Nedlands, 6009
Research Site
Newcastle, 2298
Research Site
Southport, 4215
Research Site
Sydney, NSW 2145
Research Site
Woolloongabba, 4102

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Spain12 sites

Research Site
Badalona, 8916
Research Site
Barcelona, 08041
Research Site
Barcelona, 8003
Research Site
Barcelona, 8035
Research Site
Barcelona, 8907
Research Site
Madrid, 28007
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Majadahonda, 28222
Research Site
Pamplona, 31008
Research Site
Seville
Research Site
Valencia, 46026

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Brazil11 sites

Research Site
Bela Vista, 01321-001
Research Site
Curitiba, 81520-060
Research Site
Porto Alegre, 90035-903
Research Site
Porto Alegre, RS 90610-000
Research Site
Rio de Janeiro, 20231-050
Research Site
Salvador, 41253-190
Research Site
São Paulo, 01232-010
Research Site
São Paulo, 05652-9000
Research Site
São Paulo, 1236030
Research Site
São Paulo, 5403
Research Site
So Paulo, 08270-070

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Poland10 sites

Research Site
Chorzów, 41-500
Research Site
Krakow, 30-510
Research Site
Lodz, 93-510
Research Site
Lublin, 20-090
Research Site
Olsztyn, 10-228
Research Site
Warsaw, 02-106
Research Site
Warsaw, 02-776
Research Site
Warsaw, 04-141
Research Site
Woj. Podkarpackie, 36-200
Research Site
Wroclaw, 50-367

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France9 sites

Research Site
Argenteuil, 95100
Research Site
Bobigny, 93000
Research Site
Bordeaux, 33076, FR
Research Site
Le Mans, 72000, FR
Research Site
Limoges, 87042
Research Site
Périgueux, 24019
Research Site
Pessac, 33604
Research Site
Rennes, 35000
Research Site
Vienne, 86000, FR

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Italy9 sites

Research Site
Bologna, 40138
Research Site
Milan, 20132
Research Site
Milan, 20162
Research Site
Palermo, 90146
Research Site
Parma
Research Site
Pavia, 27100
Research Site
Reggio Emilia, 42123
Research Site
Rozzano, 20089
Research Site
Turin, 10126

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South Korea8 sites

Research Site
Busan, 49201
Research Site
Gyeonggi-do, 13620
Research Site
Seoul, 3080
Research Site
Seoul, 3722
Research Site
Seoul, 5505
Research Site
Seoul, 6351
Research Site
Seoul, 6591
Research Site
Seoul, 7985

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Germany7 sites

Research Site
Heidelberg, 69120, DE
Research Site
München, 81377, DE
Research Site
Münster, 48149
Research Site
Nordrhein-Westfalen, 52064, DE
Research Site
Ravensburg, 88212
Research Site
Rheinland-Pfalz, 55131, DE
Research Site
Ulm, 89081

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Greece7 sites

Research Site
Athens, 11525
Research Site
Athens, 11527, GR
Research Site
Athens, 11528, GR
Research Site
Ioannina, 45500, GR
Research Site
Pátrai, 26504
Research Site
Thessaloniki, 54007, GR
Research Site
Thessaloniki, 57010, GR

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Argentina6 sites

Research Site
Buenos Aires, C1114AAP
Research Site
Buenos Aires, C1426ANZ
Research Site
Buenos Aires, C1430EGF
Research Site
Buenos Aires, C1431FWO
Research Site
Caba, C1118AAT
Research Site
Córdoba, 5000

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Canada6 sites

Research Site
Edmonton, T6G 1Z2
Research Site
Greenfield Park, J4V 2H1
Research Site
Halifax, NS B3H 2Y9
Research Site
Oshawa, Ontario, L1G 2B9,
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Vancouver, British Columbia, V5Z 4E6

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Hungary6 sites

Research Site
Budapest, 1085
Research Site
Budapest, 1122
Research Site
Debrecen, 4032
Research Site
Győr, 9024
Research Site
Pécs, 7624
Research Site
Szeged, 6725

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Russia6 sites

Research Site
Pyatigorsk, 357532
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197341
Research Site
Saint Petersburg
Research Site
Syktyvkar, 167029
Research Site
Tula, 300053

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Ukraine6 sites

Research Site
Cherkasy, 18009
Research Site
Chernihiv, 14029
Research Site
Dnipropetrovsk, 49102
Research Site
Kiev, 3022
Research Site
Lviv, 79044
Research Site
Zhytomyr, 10002

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Belgium5 sites

Research Site
Antwerp, 2060
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Roeselare, 8900
Research Site
Sint-Niklaas, 9100

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Czechia5 sites

Research Site
Brno, 625 00
Research Site
Hradec Králové, 500 05, CZ
Research Site
Ostrava Poruba, 708 52
Research Site
Pilsen, 30460, CZ
Research Site
Prague, 100 34, CZ

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Israel4 sites

Research Site
Haifa, 31096
Research Site
Jerusalem, 9103102
Research Site
Petah Tikva, 494142
Research Site
Tel Aviv, 64239

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Mexico4 sites

Research Site
México, 14080
Research Site
Mexico City, 2990
Research Site
Monterrey
Research Site
Querétaro, 76090

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Peru4 sites

Research Site
Arequipa, 5154
Research Site
Bellavista
Research Site
Lima, 1
Research Site
Lima, 34

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Romania4 sites

Research Site
Brasov, 50012
Research Site
Bucharest, 070131
Research Site
Cluj-Napoca, 400124
Research Site
Iași, 700483

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Taiwan4 sites

Research Site
Kaohsiung City, 833
Research Site
Taichung, 40447
Research Site
Taipei, 100
Research Site
Taoyuan, 333

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Vietnam4 sites

Research Site
Hanoi, 123
Research Site
Hanoi
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, WARD 7

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New Zealand3 sites

Research Site
Dunedin, 9016
Research Site
Grafton, 1023
Research Site
Otahuhu, 1640

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Hong Kong2 sites

Research Site
Hong Kong, 999077
Research Site
Pok Fu Lam

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About this study

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

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.

Read the 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).

Conditions: Lymphoma, Mantle Cell
Being tested: Acalabrutinib, Bendamustine, Rituximab, Placebo
Keywords: Bruton tyrosine kinase inhibitor, Acalabrutinib, Mantle Cell Lymphoma, ACE-LY-308, Treatment naive, non-Hodgkins Lymphoma, Bendomustine, Rituximab
Medical subject headings: Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcalabrutinibDrug
Also called ACP-196, Calquence
Administered orally (PO)
BendamustineDrug
Also called Treanda, Bendeka
Administered intravenously (IV)
RituximabDrug
Also called Rituxan, Rituxan Hycela
Administered intravenously (IV)
PlaceboDrug
Placebo comparator

Study groups in NCT02972840
Study group	Role	What they receive
Acalabrutinib in combination with bendamustine and rituximab	Experimental	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. Receives: Drug: Acalabrutinib; Drug: Bendamustine; Drug: Rituximab
Placebo in combination with bendamustine and rituximab	Placebo comparator	Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days. Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Up to 6 years
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.
Measured: Up to 6 years
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.
Measured: Up to 6 years
Overall survival in Arm 1 compared to Arm 2
Defined as the time from randomization until the date of death from any cause.
Measured: Up to 6 years
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.
Measured: Up to 6 years
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.
Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 201715 Feb 2027

First posted25 Nov 2016 (estimated)
Study start5 Apr 2017
Primary completion15 Feb 2027 (estimated)
Study completion15 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lymphoma, Mantle CellStudies of the same condition, open and under way.
More trials run by Acerta Pharma BVThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02972840
Sponsor's protocol ID: ACE-LY-308
Other IDs: 2023-509354-58-00, 2015-005220-26, 2015, 2023
Status last verified: Oct 2026
First submitted: 21 Nov 2016
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 40311141

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
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Auto Stem Cell Transplant for Lymphoma Patients
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Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
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All Lymphoma, Mantle Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02972840
Acronym / sponsor ID: ACE-LY-308
Conditions: Lymphoma, Mantle Cell
Keywords: Bruton tyrosine kinase inhibitor, Acalabrutinib, Mantle Cell Lymphoma, ACE-LY-308, Treatment naive, non-Hodgkins Lymphoma, Bendomustine, Rituximab
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 635 participants (actual)
Lead sponsor: Acerta Pharma BVIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: 5 Apr 2017 (actual)
Primary completion: 15 Feb 2027 (estimated)
Study completion: 15 Feb 2027 (estimated)
First posted: 25 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acalabrutinib in combination with bendamustine and rituximab	Experimental	Drug: Acalabrutinib, Drug: Bendamustine, Drug: RituximabAcalabrutinib 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 comparator	Drug: Bendamustine, Drug: Rituximab, Drug: PlaceboMatching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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 .

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcalabrutinibAlso: ACP-196, CalquenceAdministered orally (PO)	Drug	Acalabrutinib in combination with bendamustine and rituximab
BendamustineAlso: Treanda, BendekaAdministered intravenously (IV)	Drug	Acalabrutinib in combination with bendamustine and rituximab, Placebo in combination with bendamustine and rituximab
RituximabAlso: Rituxan, Rituxan HycelaAdministered intravenously (IV)	Drug	Acalabrutinib in combination with bendamustine and rituximab, Placebo in combination with bendamustine and rituximab
PlaceboPlacebo comparator	Drug	Placebo in combination with bendamustine and rituximab

Primary outcome

Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time frame: Up to 6 years
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.

6 secondary outcomes

Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time frame: Up to 6 years
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time frame: Up to 6 years
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time frame: Up to 6 years
Overall survival in Arm 1 compared to Arm 2
Time frame: Up to 6 years
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time frame: Up to 6 years
IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time frame: Up to 6 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Derived from this study: PubMed 40311141Wang 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Lymphoma, Mantle Cell

Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

228 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acalabrutinib, Bendamustine and Rituximab in people with Lymphoma, Mantle Cell, run by Acerta Pharma BV at 228 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in United States, China, Japan, Australia, Spain and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02972840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.