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

March 30, 2026 updated by: Acerta Pharma BV

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
611

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Research Site
      • Darlinghurst, Australia, 2010
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • Hobart, Australia, 7000
        • Research Site
      • Kogarah, Australia, 2217
        • Research Site
      • Nedlands, Australia, 6009
        • Research Site
      • Westmead, Australia, 2145
        • Research Site
  • Austria
      • Linz, Austria, 4021
        • Research Site
      • Wels, Austria, 4600
        • Research Site
  • Belgium
      • Antwerp, Belgium, 2060
        • Research Site
      • Bruges, Belgium, 8000
        • Research Site
  • Brazil
      • Goiânia, Brazil, 74605-020
        • Research Site
      • Passo Fundo, Brazil, 99010-260
        • Research Site
      • Porto Alegre, Brazil, 90619-900
        • Research Site
      • Porto Alegre, Brazil, 90110-270
        • Research Site
      • Ribeirão Preto, Brazil, 14051-140
        • Research Site
      • Rio de Janeiro, Brazil, 22793-080
        • Research Site
      • São Paulo, Brazil, 08270-070
        • Research Site
      • São Paulo, Brazil, 01509-900
        • Research Site
      • São Paulo, Brazil, 01236-030
        • Research Site
      • São Paulo, Brazil, 04029-000
        • Research Site
  • Canada
      • Ottawa, Canada, K1H 8L6
        • Research Site
      • Toronto, Canada, M4N 3M5
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • CA
      • Toronto, CA, Canada, M5G 2M9
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Research Site
    • Quebec
      • Lévis, Quebec, Canada, G6V 0B8
        • Research Site
      • Montreal, Quebec, Canada, H2X 3E4
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Québec, Quebec, Canada, G1J 1Z4
        • Research Site
  • China
      • Beijing, China, 100044
        • Research Site
      • Beijing, China, 100191
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Guangzhou, China, 510120
        • Research Site
      • Guangzhou, China, 510080
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Hangzhou, China, 310003
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Jinan, China, 250117
        • Research Site
      • Luoyang, China, 471003
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanning, China, 530021
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China
        • Research Site
      • Shenyang, China, 110042
        • Research Site
      • Shenyang, China, 110004
        • Research Site
      • Shijiazhuang, China, 050020
        • Research Site
      • Suzhou, China, 215006
        • Research Site
      • Tianjin, China, 300060
        • Research Site
      • Tianjin, China, 300020
        • Research Site
      • Wuhan, China, 430022
        • Research Site
      • Wuhan, China, 430030
        • Research Site
      • Xiamen, China, 361003
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
      • Hradec Králové, Czechia, 500 05
        • Research Site
      • Ostrava - Poruba, Czechia, 708 52
        • Research Site
      • Pilsen, Czechia, 304 60
        • Research Site
      • Prague, Czechia, 100 34
        • Research Site
      • Prague, Czechia, 128 08
        • Research Site
  • France
      • Brest, France, 29609
        • Research Site
      • Caen, France, 14033
        • Research Site
      • Marseille, France, 13385
        • Research Site
      • Montpellier, France, 34295
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Pierre-Bénite, France, 69495
        • Research Site
      • Rennes, France, 35033
        • Research Site
      • Toulouse, France, 31100
        • Research Site
  • Germany
      • Bamberg, Germany, 96049
        • Research Site
      • Berlin, Germany, 10967
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Homburg, Germany, 66421
        • Research Site
      • Neumünster, Germany, 24534
        • Research Site
  • India
      • Bangalore, India, 560064
        • Research Site
      • Delhi, India, 110029
        • Research Site
      • Kochi, India, 682041
        • Research Site
      • Mumbai, India, 400 012
        • Research Site
      • Nashik, India, 422004
        • Research Site
      • Nashik, India, 422009
        • Research Site
      • Pune, India, 411001
        • Research Site
  • Israel
      • Afula, Israel, 18101
        • Research Site
      • Ashdod, Israel, 7747629
        • Research Site
      • Beersheba, Israel, 8410101
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Haifa, Israel, 31048
        • Research Site
      • Holon, Israel, 58100
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Nahariya, Israel, 22100
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
      • Tel Aviv, Israel, 6423906
        • Research Site
      • Ẕerifin, Israel, 70300
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Bergamo, Italy, 24127
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Meldola, Italy, 47014
        • Research Site
      • Milan, Italy, 20141
        • Research Site
      • Milan, Italy, 20162
        • Research Site
      • Novara, Italy, 28100
        • Research Site
      • Palermo, Italy, 90146
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Pisa, Italy, 56126
        • Research Site
      • Ravenna, Italy, 48121
        • Research Site
      • Reggio Emilia, Italy, 42123
        • Research Site
      • Roma, Italy, 00152
        • Research Site
      • Roma, Italy, 00144
        • Research Site
      • Siena, Italy, 53100
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Tricase, Italy, 73039
        • Research Site
      • Venezia, Italy, 30174
        • Research Site
  • Japan
      • Chiba, Japan, 260-8717
        • Research Site
      • Chūōku, Japan, 104-0045
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Itabashi-ku, Japan, 173-8610
        • Research Site
      • Kahoku-gun, Japan, 920-0293
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
      • Kobe, Japan, 650-0047
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Research Site
      • Kumamoto, Japan, 860-0008
        • Research Site
      • Kyoto, Japan, 602-8026
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Research Site
      • Nagasaki, Japan, 852-8501
        • Research Site
      • Nagoya, Japan, 466-8560
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Nagoya, Japan, 460-0001
        • Research Site
      • Niigata, Japan, 951-8520
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka, Japan, 545-8586
        • Research Site
      • Sapporo, Japan, 003-0006
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Shimotsuke-shi, Japan, 329-0498
        • Research Site
      • Tsu, Japan, 514-8507
        • Research Site
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
  • Poland
      • Gdansk, Poland, 80-952
        • Research Site
      • Krakow, Poland, 30-510
        • Research Site
      • Lodz, Poland, 93-510
        • Research Site
      • Lublin, Poland, 20-081
        • Research Site
      • Warsaw, Poland, 02-776
        • Research Site
      • Wroclaw, Poland, 50-367
        • Research Site
  • Portugal
      • Braga, Portugal, 4710
        • Research Site
      • Lisbon, Portugal, 1649-035
        • Research Site
      • Lisbon, Portugal, 1998-018
        • Research Site
      • Lisbon, Portugal, 1400-038
        • Research Site
      • Matosinhos Municipality, Portugal, 4454-509
        • Research Site
      • Porto, Portugal, 4099-001
        • Research Site
      • Porto, Portugal, 4200-319
        • Research Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Research Site
  • Russia
      • Chelyabinsk, Russia, 454087
        • Research Site
      • Moscow, Russia, 125284
        • Research Site
      • Saint Petersburg, Russia, 197022
        • Research Site
      • Saint Petersburg, Russia, 194291
        • Research Site
  • South Korea
      • Busan, South Korea, 49241
        • Research Site
      • Busan, South Korea, 49201
        • Research Site
      • Goyang-si, South Korea, 10408
        • Research Site
      • Jeonju, South Korea, 54907
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 6351
        • Research Site
      • Seoul, South Korea, 06591
        • Research Site
      • Seoul, South Korea, 5505
        • Research Site
      • Suwon, South Korea, 16499
        • Research Site
  • Spain
      • Alcalá de Henares, Spain, 28805
        • Research Site
      • Badalona, Spain, 08003
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Gijón, Spain, 33394
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08908
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Madrid, Spain, 28033
        • Research Site
      • Palma, Spain, 07198
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Pozuelo de Alarcón, Spain, 28223
        • Research Site
      • Salamanca, Spain, 37007
        • Research Site
      • Seville, Spain, 41013
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Research Site
      • Tainan, Taiwan, 736
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6500
        • Research Site
      • Ankara, Turkey (Türkiye), 6200
        • Research Site
      • Ankara, Turkey (Türkiye), 06700
        • Research Site
      • Balçova, Turkey (Türkiye), 35340
        • Research Site
      • Edirne, Turkey (Türkiye), 22030
        • Research Site
      • Izmir, Turkey (Türkiye), 35040
        • Research Site
      • Kayseri, Turkey (Türkiye), 38030
        • Research Site
      • Mersin, Turkey (Türkiye), 33079
        • Research Site
      • Samsun, Turkey (Türkiye), 55139
        • Research Site
      • Trabzon, Turkey (Türkiye), 61080
        • Research Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Research Site
      • Khmelnytskyi, Ukraine, 29000
        • Research Site
      • Kyiv, Ukraine, 03022
        • Research Site
      • Kyiv, Ukraine, 04112
        • Research Site
      • Lviv, Ukraine, 79044
        • Research Site
      • Mykolayiv, Ukraine, 54058
        • Research Site
      • Zaporizhzhia, Ukraine, 69600
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Irvine, California, United States, 92618
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Research Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
      • St. Petersburg, Florida, United States, 33705-1449
        • Research Site
      • Tallahassee, Florida, United States, 32308-5304
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63129
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Research Site
      • New York, New York, United States, 10065
        • Research Site
      • New York, New York, United States, 10028
        • Research Site
      • Stony Brook, New York, United States, 11795
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Research Site
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Research Site
      • Lubbock, Texas, United States, 79410
        • Research Site
    • Virginia
      • Salem, Virginia, United States, 24153
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: acalabrutinib + R-CHOP
Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Drug: acalabrutinib
Investigational Product
Drug: Prednisone
Investigational Product
Drug: Rituximab
Investigational Product
Drug: Cyclophosphamide
Investigational Product
Drug: Vincristine
Investigational Product
Drug: Doxorubicin
Investigational Product
Placebo Comparator: placebo + R-CHOP
Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
Drug: Prednisone
Investigational Product
Drug: Rituximab
Investigational Product
Drug: Cyclophosphamide
Investigational Product
Drug: Vincristine
Investigational Product
Drug: Doxorubicin
Investigational Product
Drug: placebo
Placebo comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
at every single visit up to 60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
at every single visit up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acerta Pharma BV

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8227C00001
  • 2019-001755-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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