Diffuse Large B-Cell LymphomaPhase 3ESCALADENCT04529772

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

A Phase 3 study testing acalabrutinib, Prednisone and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by Acerta Pharma BV at 245 sites in 23 countries.

Active, not recruiting

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

Official record

Search all trials

Trial summary

Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diffuse Large B-Cell Lymphoma
What is being tested?: acalabrutinib, Prednisone and Rituximab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 611 participants
Where: 245 sitesin 23 countries
Study dates: 8 Oct 2020to 22 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women, age ≥18 and ≤75 years
Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
No prior treatment for DLBCL
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
International Prognostic Index (IPI) score of 1 to 5
Disease Stage II to IV by the Ann Arbor Classification
Adequate organ and marrow function
Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab

Who cannot join

Evidence of severe or uncontrolled systemic diseases
Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
History of stroke or intracranial haemorrhage in preceding 6 months.
Known CNS lymphoma or leptomeningeal disease
Known primary mediastinal lymphoma
Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements

Show all 12Show fewer

Prior history of indolent lymphoma or CLL
History of or ongoing confirmed PML
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
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
Prior anthracycline use ≥150 mg/m2

Trial locations and contacts

245 sites in 23 countries.

Country

City, postcode or hospital

245 sites in 23 countries

United States32 sites

Research Site
Albany, New York, 12208
Research Site
Aurora, Colorado, 80012
Research Site
Baltimore, Maryland, 21201
Research Site
Charlotte, North Carolina, 28204
Research Site
Des Moines, Iowa, 50309
Research Site
Eugene, Oregon, 97401
Research Site
Fort Myers, Florida, 33901
Research Site
Fort Sam Houston, Texas, 78234
Research Site
Fort Wayne, Indiana, 46845
Research Site
Grand Rapids, Michigan, 49503
Research Site
Irvine, California, 92618
Research Site
Little Rock, Arkansas, 72205
Research Site
Louisville, Kentucky, 40207
Research Site
Lubbock, Texas, 79410
Research Site
Minneapolis, Minnesota, 55407
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10028
Research Site
New York, New York, 10065
Research Site
Norwich, Connecticut, 06360
Research Site
Orlando, Florida, 32804
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Portland, Oregon, 97239
Research Site
Salem, Virginia, 24153
Research Site
St Louis, Missouri, 63129
Research Site
St. Petersburg, Florida, 33705-1449
Research Site
Stony Brook, New York, 11795
Research Site
Tallahassee, Florida, 32308-5304
Research Site
Tucson, Arizona, 85711
Research Site
West Palm Beach, Florida, 33401
Research Site
Wichita, Kansas, 67214
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

China26 sites

Research Site
Beijing, 100044
Research Site
Beijing, 100191
Research Site
Changchun, 130021
Research Site
Chengdu, 610041
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510120
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310009
Research Site
Harbin, 150081
Research Site
Jinan, 250117
Research Site
Luoyang, 471003
Research Site
Nanchang, 330006
Research Site
Nanning, 530021
Research Site
Shanghai, 200032
Research Site
Shanghai
Research Site
Shenyang, 110004
Research Site
Shenyang, 110042
Research Site
Shijiazhuang, 050020
Research Site
Suzhou, 215004
Research Site
Tianjin, 300020
Research Site
Tianjin, 300060
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030
Research Site
Xiamen, 361003
Research Site
Zhengzhou, 450008

Other trials in China

Japan23 sites

Research Site
Chiba, 260-8717
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 812-8582
Research Site
Kahoku-gun, 920-0293
Research Site
Kashiwa, 277-8577
Research Site
Kobe, 650-0047
Research Site
Kōtoku, 135-8550
Research Site
Kumamoto, 860-0008
Research Site
Kumamoto, 860-8556
Research Site
Kyoto, 602-8026
Research Site
Matsuyama, 791-0280
Research Site
Nagasaki, 852-8501
Research Site
Nagoya, 460-0001
Research Site
Nagoya, 464-8681
Research Site
Nagoya, 466-8560
Research Site
Niigata, 951-8520
Research Site
Okayama, 700-8558
Research Site
Osaka, 545-8586
Research Site
Sapporo, 003-0006
Research Site
Sendai, 980-8574
Research Site
Shimotsuke-shi, 329-0498
Research Site
tabashi City, 173-8610
Research Site
Tsu, 514-8507

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Italy20 sites

Research Site
Bari, 70124
Research Site
Bergamo, 24127
Research Site
Bologna, 40138
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Meldola, 47014
Research Site
Milan, 20141
Research Site
Milan, 20162
Research Site
Novara, 28100
Research Site
Palermo, 90146
Research Site
Pavia, 27100
Research Site
Pisa, 56126
Research Site
Ravenna, 48121
Research Site
Reggio Emilia, 42123
Research Site
Roma, 00144
Research Site
Roma, 00152
Research Site
Siena, 53100
Research Site
Torino, 10126
Research Site
Tricase, 73039
Research Site
Venezia, 30174

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Spain16 sites

Research Site
Alcalá de Henares, 28805
Research Site
Badalona, 08003
Research Site
Barcelona, 08035
Research Site
Gijón, 33394
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Madrid, 28007
Research Site
Madrid, 28033
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Palma, 07198
Research Site
Pamplona, 31008
Research Site
Pozuelo de Alarcón, 28223
Research Site
Salamanca, 37007
Research Site
Seville, 41013
Research Site
Valencia, 46026

Other trials in Spain

Israel14 sites

Research Site
Afula, 18101
Research Site
Ashdod, 7747629
Research Site
Beersheba, 8410101
Research Site
Haifa, 31048
Research Site
Haifa, 31096
Research Site
Haifa, 34362
Research Site
Holon, 58100
Research Site
Jerusalem, 91031
Research Site
Jerusalem, 91120
Research Site
Nahariya, 22100
Research Site
Petah Tikva, 4941492
Research Site
Ramat Gan, 52621
Research Site
Tel Aviv, 6423906
Research Site
Tsrifin, 70300

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Brazil10 sites

Research Site
Goiânia, 74605-020
Research Site
Passo Fundo, 99010-260
Research Site
Porto Alegre, 90110-270
Research Site
Porto Alegre, 90619-900
Research Site
Ribeirão Preto, 14051-140
Research Site
Rio de Janeiro, 22793-080
Research Site
São Paulo, 01236-030
Research Site
São Paulo, 01509-900
Research Site
São Paulo, 04029-000
Research Site
São Paulo, 08270-070

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Canada10 sites

Research Site
Lévis, Quebec, G6V 0B8
Research Site
London, Ontario, N6A 5W9
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H2X 3E4
Research Site
Ottawa, K1H 8L6
Research Site
Québec, Quebec, G1J 1Z4
Research Site
Toronto, CA, M5G 2M9
Research Site
Toronto, M4N 3M5
Research Site
Vancouver, British Columbia, V5Z 4E6
Research Site
Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

South Korea10 sites

Research Site
Busan, 49201
Research Site
Busan, 49241
Research Site
Goyang-si, 10408
Research Site
Jeonju, 54907
Research Site
Seoul, 03080
Research Site
Seoul, 06591
Research Site
Seoul, 3722
Research Site
Seoul, 5505
Research Site
Seoul, 6351
Research Site
Suwon, 16499

Other trials in South Korea

Turkey (Türkiye)10 sites

Research Site
Ankara, 06700
Research Site
Ankara, 6200
Research Site
Ankara, 6500
Research Site
Balçova, 35340
Research Site
Edirne, 22030
Research Site
Izmir, 35040
Research Site
Kayseri, 38030
Research Site
Mersin, 33079
Research Site
Samsun, 55139
Research Site
Trabzon, 61080

Other trials in Turkey (Türkiye)

France9 sites

Research Site
Brest, 29609
Research Site
Caen, 14033
Research Site
Marseille, 13385
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Pessac, 33604
Research Site
Pierre-Bénite, 69495
Research Site
Rennes, 35033
Research Site
Toulouse, 31100

Other trials in France

Australia8 sites

Research Site
Adelaide, 5000
Research Site
Camperdown, 2050
Research Site
Darlinghurst, 2010
Research Site
Heidelberg, 3084
Research Site
Hobart, 7000
Research Site
Kogarah, 2217
Research Site
Nedlands, 6009
Research Site
Westmead, 2145

Other trials in Australia

Portugal8 sites

Research Site
Braga, 4710
Research Site
Lisbon, 1400-038
Research Site
Lisbon, 1649-035
Research Site
Lisbon, 1998-018
Research Site
Matosinhos Municipality, 4454-509
Research Site
Porto, 4099-001
Research Site
Porto, 4200-319
Research Site
Vila Nova de Gaia, 4434-502

Other trials in Portugal

India7 sites

Research Site
Bangalore, 560064
Research Site
Delhi, 110029
Research Site
Kochi, 682041
Research Site
Mumbai, 400 012
Research Site
Nashik, 422004
Research Site
Nashik, 422009
Research Site
Pune, 411001

Other trials in India

Taiwan7 sites

Research Site
Kaohsiung City, 833
Research Site
Tainan, 70403
Research Site
Tainan, 736
Research Site
Taipei, 100
Research Site
Taipei, 235
Research Site
Taipei
Research Site
Taoyuan City

Other trials in Taiwan

Ukraine7 sites

Research Site
Cherkasy, 18009
Research Site
Khmelnytskyi, 29000
Research Site
Kyiv, 03022
Research Site
Kyiv, 04112
Research Site
Lviv, 79044
Research Site
Mykolayiv, 54058
Research Site
Zaporizhzhya, 69600

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Czechia6 sites

Research Site
Brno, 625 00
Research Site
Hradec Králové, 500 05
Research Site
Ostrava - Poruba, 708 52
Research Site
Pilsen, 304 60
Research Site
Prague, 100 34
Research Site
Prague, 128 08

Other trials in Czechia

Poland6 sites

Research Site
Gdansk, 80-952
Research Site
Krakow, 30-510
Research Site
Lodz, 93-510
Research Site
Lublin, 20-081
Research Site
Warsaw, 02-776
Research Site
Wroclaw, 50-367

Other trials in Poland

Germany5 sites

Research Site
Bamberg, 96049
Research Site
Berlin, 10967
Research Site
Dresden, 01307
Research Site
Homburg, 66421
Research Site
Neumünster, 24534

Other trials in Germany

Russia4 sites

Research Site
Chelyabinsk, 454087
Research Site
Moscow, 125284
Research Site
Saint Petersburg, 194291
Research Site
Saint Petersburg, 197022

Other trials in Russia

Belgium3 sites

Research Site
Antwerp, 2060
Research Site
Bruges, 8000
Research Site
La Louvière, 7100

Other trials in Belgium

Austria2 sites

Research Site
Linz, 4021
Research Site
Wels, 4600

Other trials in Austria

Mexico2 sites

Research Site
Chihuahua City, 31000
Research Site
Monterrey, 64460

Other trials in Mexico

About this study

Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

Read the detailed description

Phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as compared with placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma (activated B-cell (ABC) and unclassified).

Conditions: Diffuse Large B-Cell Lymphoma
Being tested: acalabrutinib, placebo, Prednisone, Rituximab, Cyclophosphamide
Keywords: Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Lymphoma, Non-Hodgkin, Prednisone, Cyclophosphamide, Rituximab, Doxorubicin, Vincristine, Acalabrutinib, Calquence
Medical subject headings: Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, B-Cell, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Lymphoma, Non-Hodgkin

What participants receive

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

acalabrutinibDrug
Investigational Product
placeboDrug
Placebo comparator
PrednisoneDrug
Investigational Product
RituximabDrug
Investigational Product
CyclophosphamideDrug
Investigational Product
VincristineDrug
Investigational Product
DoxorubicinDrug
Investigational Product

Study groups in NCT04529772
Study group	Role	What they receive
acalabrutinib + R-CHOP	Experimental	Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Receives: Drug: acalabrutinib; Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin
placebo + R-CHOP	Placebo comparator	Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Receives: Drug: placebo; Drug: Prednisone; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin

What is being measured

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

Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B
Measured: at every single visit up to 60 months

Secondary outcomes (3)

Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B
Measured: at every single visit up to 60 months
Overall survival in Arm A compared to Arm B
Measured: at every single visit up to 60 months
Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL
Measured: at every single visit up to 60 months

Timeline

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

8 Oct 202022 Feb 2027

First posted28 Aug 2020
Study start8 Oct 2020
Primary completion22 Feb 2027 (estimated)
Study completion22 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diffuse Large B-Cell LymphomaStudies 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
Model description: Double-blind Randomised Placebo-controlled Study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 611 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04529772
Sponsor's protocol ID: D8227C00001
Other IDs: 2019-001755-39, 2019
Acronym: ESCALADE
Status last verified: Oct 2026
First submitted: 25 Aug 2020
Last updated: 13 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.

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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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL
ClinicalTrials.gov ID: NCT04529772
Acronym / sponsor ID: ESCALADE / D8227C00001
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Lymphoma, Non-Hodgkin
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 611 participants (actual)
Lead sponsor: Acerta Pharma BVIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: 8 Oct 2020 (actual)
Primary completion: 22 Feb 2027 (estimated)
Study completion: 22 Feb 2027 (estimated)
First posted: 28 Aug 2020 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-blind Randomised Placebo-controlled Study

Arm	Type	Receives
acalabrutinib + R-CHOP	Experimental	Drug: acalabrutinib, Drug: Prednisone, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Vincristine, Drug: DoxorubicinAcalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
placebo + R-CHOP	Placebo comparator	Drug: placebo, Drug: Prednisone, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Vincristine, Drug: DoxorubicinPlacebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men and women, age ≥18 and ≤75 years
Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
No prior treatment for DLBCL
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
International Prognostic Index (IPI) score of 1 to 5

Key exclusion criteria (12 listed)

Evidence of severe or uncontrolled systemic diseases
Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
History of stroke or intracranial haemorrhage in preceding 6 months.
Known CNS lymphoma or leptomeningeal disease
Known primary mediastinal lymphoma

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
acalabrutinibInvestigational Product	Drug	acalabrutinib + R-CHOP
placeboPlacebo comparator	Drug	placebo + R-CHOP
PrednisoneInvestigational Product	Drug	acalabrutinib + R-CHOP, placebo + R-CHOP
RituximabInvestigational Product	Drug	acalabrutinib + R-CHOP, placebo + R-CHOP
CyclophosphamideInvestigational Product	Drug	acalabrutinib + R-CHOP, placebo + R-CHOP
VincristineInvestigational Product	Drug	acalabrutinib + R-CHOP, placebo + R-CHOP
DoxorubicinInvestigational Product	Drug	acalabrutinib + R-CHOP, placebo + R-CHOP

Primary outcome

Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B
Time frame: at every single visit up to 60 months

3 secondary outcomes

Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B
Time frame: at every single visit up to 60 months
Overall survival in Arm A compared to Arm B
Time frame: at every single visit up to 60 months
Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL
Time frame: at every single visit up to 60 months

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 13 Oct 2026.
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.

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Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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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.

245 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing acalabrutinib, Prednisone and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by Acerta Pharma BV at 245 sites in 23 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 8 inclusion and 12 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 13 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 245 sites in United States, China, Japan, Italy, Spain and 18 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 (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B (time frame: at every single visit up to 60 months). 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 NCT04529772.

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 13 Oct 2026.