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.
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
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.
245 sites in 23 countries
United States32 sites
Research Site
Albany, New York, 12208
Research Site
Aurora, Colorado, 80012
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Baltimore, Maryland, 21201
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Charlotte, North Carolina, 28204
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Des Moines, Iowa, 50309
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Eugene, Oregon, 97401
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Fort Myers, Florida, 33901
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Fort Sam Houston, Texas, 78234
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Fort Wayne, Indiana, 46845
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Grand Rapids, Michigan, 49503
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Irvine, California, 92618
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Little Rock, Arkansas, 72205
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Louisville, Kentucky, 40207
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Lubbock, Texas, 79410
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Minneapolis, Minnesota, 55407
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Nashville, Tennessee, 37203
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New York, New York, 10028
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New York, New York, 10065
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Norwich, Connecticut, 06360
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Orlando, Florida, 32804
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Philadelphia, Pennsylvania, 19111
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Pittsburgh, Pennsylvania, 15212
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Portland, Oregon, 97239
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Salem, Virginia, 24153
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St Louis, Missouri, 63129
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St. Petersburg, Florida, 33705-1449
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Stony Brook, New York, 11795
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Tallahassee, Florida, 32308-5304
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Tucson, Arizona, 85711
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West Palm Beach, Florida, 33401
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Wichita, Kansas, 67214
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Winston-Salem, North Carolina, 27103
China26 sites
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Beijing, 100044
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Beijing, 100191
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Changchun, 130021
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Chengdu, 610041
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Guangzhou, 510060
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Guangzhou, 510080
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Guangzhou, 510120
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Hangzhou, 310003
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Hangzhou, 310009
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Harbin, 150081
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Jinan, 250117
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Luoyang, 471003
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Nanchang, 330006
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Nanning, 530021
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Shanghai, 200032
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Shanghai
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Shenyang, 110004
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Shenyang, 110042
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Shijiazhuang, 050020
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Suzhou, 215004
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Tianjin, 300020
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Tianjin, 300060
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Wuhan, 430022
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Wuhan, 430030
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Xiamen, 361003
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Zhengzhou, 450008
Japan23 sites
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Chiba, 260-8717
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Chūōku, 104-0045
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Fukuoka, 812-8582
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Itabashi-ku, 173-8610
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Kahoku-gun, 920-0293
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Kashiwa, 277-8577
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Kobe, 650-0047
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Kōtoku, 135-8550
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Kumamoto, 860-0008
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Kumamoto, 860-8556
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Kyoto, 602-8026
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Matsuyama, 791-0280
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Nagasaki, 852-8501
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Nagoya, 460-0001
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Nagoya, 464-8681
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Nagoya, 466-8560
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Niigata, 951-8520
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Okayama, 700-8558
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Osaka, 545-8586
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Sapporo, 003-0006
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Sendai, 980-8574
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Shimotsuke-shi, 329-0498
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Tsu, 514-8507
Italy20 sites
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Bari, 70124
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Bergamo, 24127
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Bologna, 40138
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Florence, 50134
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Genova, 16132
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Meldola, 47014
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Milan, 20141
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Milan, 20162
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Novara, 28100
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Palermo, 90146
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Pavia, 27100
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Pisa, 56126
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Ravenna, 48121
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Reggio Emilia, 42123
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Roma, 00144
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Roma, 00152
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Siena, 53100
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Torino, 10126
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Tricase, 73039
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Venezia, 30174
Spain16 sites
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Alcalá de Henares, 28805
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Badalona, 08003
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Barcelona, 08035
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Gijón, 33394
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L'Hospitalet de Llobregat, 08908
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Madrid, 28007
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Madrid, 28033
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Madrid, 28034
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Madrid, 28040
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Madrid, 28046
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Palma, 07198
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Pamplona, 31008
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Pozuelo de Alarcón, 28223
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Salamanca, 37007
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Seville, 41013
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Valencia, 46026
Israel14 sites
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Afula, 18101
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Ashdod, 7747629
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Beersheba, 8410101
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Haifa, 31048
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Haifa, 31096
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Haifa, 34362
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Holon, 58100
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Jerusalem, 91031
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Jerusalem, 91120
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Nahariya, 22100
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Petah Tikva, 4941492
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Ramat Gan, 52621
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Tel Aviv, 6423906
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Ẕerifin, 70300
Brazil10 sites
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Goiânia, 74605-020
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Passo Fundo, 99010-260
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Porto Alegre, 90110-270
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Porto Alegre, 90619-900
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Ribeirão Preto, 14051-140
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Rio de Janeiro, 22793-080
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São Paulo, 01236-030
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São Paulo, 01509-900
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São Paulo, 04029-000
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São Paulo, 08270-070
Canada10 sites
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Lévis, Quebec, G6V 0B8
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London, Ontario, N6A 5W9
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2X 3E4
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Ottawa, K1H 8L6
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Québec, Quebec, G1J 1Z4
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Toronto, CA, M5G 2M9
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Toronto, M4N 3M5
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Vancouver, British Columbia, V5Z 4E6
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Winnipeg, Manitoba, R3E 0V9
South Korea10 sites
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Busan, 49201
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Busan, 49241
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Goyang-si, 10408
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Jeonju, 54907
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Seoul, 03080
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Seoul, 06591
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Seoul, 3722
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Seoul, 5505
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Seoul, 6351
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Suwon, 16499
Turkey (Türkiye)10 sites
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Ankara, 06700
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Ankara, 6200
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Ankara, 6500
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Balçova, 35340
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Edirne, 22030
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Izmir, 35040
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Kayseri, 38030
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Mersin, 33079
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Samsun, 55139
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Trabzon, 61080
France9 sites
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Brest, 29609
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Caen, 14033
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Marseille, 13385
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Montpellier, 34295
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Nantes, 44093
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Pessac, 33604
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Pierre-Bénite, 69495
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Rennes, 35033
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Toulouse, 31100
Australia8 sites
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Adelaide, 5000
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Camperdown, 2050
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Darlinghurst, 2010
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Heidelberg, 3084
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Hobart, 7000
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Kogarah, 2217
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Nedlands, 6009
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Westmead, 2145
Portugal8 sites
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Braga, 4710
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Lisbon, 1400-038
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Lisbon, 1649-035
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Lisbon, 1998-018
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Matosinhos Municipality, 4454-509
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Porto, 4099-001
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Porto, 4200-319
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Vila Nova de Gaia, 4434-502
India7 sites
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Bangalore, 560064
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Delhi, 110029
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Kochi, 682041
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Mumbai, 400 012
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Nashik, 422004
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Nashik, 422009
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Pune, 411001
Taiwan7 sites
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Kaohsiung City, 833
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Tainan, 70403
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Tainan, 736
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Taipei, 100
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Taipei, 235
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Taipei
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Taoyuan City
Ukraine7 sites
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Cherkasy, 18009
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Khmelnytskyi, 29000
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Kyiv, 03022
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Kyiv, 04112
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Lviv, 79044
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Mykolayiv, 54058
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Zaporizhzhya, 69600
Czechia6 sites
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Brno, 625 00
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Hradec Králové, 500 05
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Ostrava - Poruba, 708 52
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Pilsen, 304 60
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Prague, 100 34
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Prague, 128 08
Poland6 sites
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Gdansk, 80-952
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Krakow, 30-510
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Lodz, 93-510
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Lublin, 20-081
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Warsaw, 02-776
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Wroclaw, 50-367
Germany5 sites
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Bamberg, 96049
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Berlin, 10967
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Dresden, 01307
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Homburg, 66421
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Neumünster, 24534
Russia4 sites
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Chelyabinsk, 454087
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Moscow, 125284
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Saint Petersburg, 194291
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Saint Petersburg, 197022
Belgium3 sites
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Antwerp, 2060
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Bruges, 8000
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La Louvière, 7100
Mexico2 sites
Research Site
Chihuahua City, 31000
Research Site
Monterrey, 64460
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
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 lymphoma.
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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
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.