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Trial record 1 of 1 for:    ACE-CL-311
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Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836261
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Acalabrutinib Drug: Venetoclax Drug: Chemoimmunotherapy Drug: Obinutuzumab Phase 3

Detailed Description:

This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure.

The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : March 26, 2024
Estimated Study Completion Date : March 26, 2024


Arm Intervention/treatment
Experimental: Acalabrutinib, Venetoclax
Acalabrutinib in combination with Venetoclax
Drug: Acalabrutinib
Acalabrutinib,
Other Name: Calquence (acalabrutinib)

Drug: Venetoclax
Venetoclax
Other Name: Venclyxto, Venclexta

Experimental: Acalabrutinib, Venetoclax, Obinutuzumab
Acalabrutinib in combination with Venetoclax with or without Obinutuzumab
Drug: Acalabrutinib
Acalabrutinib,
Other Name: Calquence (acalabrutinib)

Drug: Venetoclax
Venetoclax
Other Name: Venclyxto, Venclexta

Drug: Obinutuzumab
Obinutuzumab
Other Name: Gazyva, Gazyvaro

Active Comparator: Chemoimmunotherapy

Chemoimmunotherapy

FCR: Fludarabine, Cyclophosphamide and Rituximab

Drug: Chemoimmunotherapy
fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)




Primary Outcome Measures :
  1. To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS [ Time Frame: 6 years ]
    Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the Independent Review Committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria


Secondary Outcome Measures :
  1. To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS [ Time Frame: 6 years ]
    PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the IRC assessment and investigator assessment

  2. To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared with FCR or BR (Arm C): PFS defined the same as above per investigator assessment. [ Time Frame: 6 years ]
    PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the IRC assessment and investigator assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)
  • Active disease per IWCLL 2018 criteria that requires treatment.
  • Participants must use highly effective birth control throughout the study.

Exclusion Criteria:

  • Any prior CLL-specific therapies.
  • Detected del(17p) or TP53 mutation.
  • Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia [PLL], or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia.
  • History of confirmed progressive multifocal leukoencephalopathy (PML).
  • Received any investigational drug within 30 days before first dose of study drug.
  • Major surgical procedure within 30 days before the first dose of study drug.
  • Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
  • Received a live virus vaccination within 28 days of first dose of study drug.
  • Known history of infection with human immunodeficiency virus (HIV).
  • Serologic status reflecting active hepatitis B or C infection.
  • History of known hypersensitivity or anaphylactic reactions to study drugs or excipients.
  • History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
  • Known bleeding disorders.
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
  • Female participants must not be breastfeeding or pregnant.
  • Concurrent participation in another therapeutic clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836261


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, California
Research Site Not yet recruiting
Fountain Valley, California, United States, 92708
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Fullerton, California, United States, 92835
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Los Angeles, California, United States, 90095
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Redondo Beach, California, United States, 90277
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Santa Barbara, California, United States, 93105
United States, Florida
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Orlando, Florida, United States, 32806
United States, Indiana
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Fort Wayne, Indiana, United States, 46808
United States, Kansas
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Wichita, Kansas, United States, 67214
United States, Kentucky
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Louisville, Kentucky, United States, 40207
United States, Louisiana
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New Orleans, Louisiana, United States, 70056
United States, Maryland
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Baltimore, Maryland, United States, 21201
United States, Massachusetts
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Boston, Massachusetts, United States, 02215
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Boston, Massachusetts, United States, 02215
United States, New Jersey
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Brick, New Jersey, United States, 08724
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Florham Park, New Jersey, United States, 07932
United States, New York
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New York, New York, United States, 10032
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New York, New York, United States, 11021
United States, North Carolina
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Charlotte, North Carolina, United States, 28204
United States, Ohio
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Canton, Ohio, United States, 44718
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
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Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
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San Antonio, Texas, United States, 78234
United States, Washington
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
Argentina
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Buenos Aires, Argentina, 1114
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Buenos Aires, Argentina, C1426ANZ
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Capital Federal, Argentina, 1118
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Ciudad Autonoma Buenos Aires, Argentina, C1181ACH
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Córdoba, Argentina, 5000
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Córdoba, Argentina, X5016KEH
Australia
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Adelaide, Australia, 5000
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Darlinghurst, Australia, 2010
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Heidelberg, Australia, 3084
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Kogarah, Australia, 2217
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Melbourne, Australia, 3000
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Nedlands, Australia, 6009
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Waratah, Australia, 2298
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Woolloongabba, Australia, 4102
Austria
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Krems, Austria, 3500
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Salzburg, Austria, 5020
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Vienna, Austria, 1140
Belgium
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Yvoir, Belgium, 5530
Brazil
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Goiania, Brazil, 74605-020
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Hangzhou, Brazil, 310003
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Monterrey, Brazil, 64570
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Porto Alegre, Brazil, 90020-090
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Porto Alegre, Brazil, 90035-003
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Porto Alegre, Brazil, 90470-340
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Rio de Janeiro, Brazil, 20230-130
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Rio de Janeiro, Brazil, 22793-080
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Sao Paulo, Brazil, 01236-030
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Sao Paulo, Brazil, 01509-900
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São Paulo, Brazil, 01308-050
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São Paulo, Brazil, 05403-000
Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1606
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Vratsa, Bulgaria, 3000
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Montreal, Quebec, Canada, H4J 1C5
China
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Beijing, China, 100034
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Beijing, China, 100044
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Beijing, China, 100191
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Changchun, China, 130021
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Changsha, China, 410008
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Chengdu, China, 610041
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Chongqing, China, 400037
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Fuzhou, China, 350009
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Guangzhou, China, 510100
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Guangzhou, China, 510515
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Haikou, China, 570311
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Hankou,Wuhan, China, 430022
Research Site Withdrawn
Jinan, China, 250012
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Lanzhou, China, 730050
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Nanchang, China, 330006
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Shanghai, China, 200025
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Shenyang, China, 110001
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Shenzhen, China, 518039
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Tianjin, China, 300020
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Urumchi, China, 830054
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Wenzhou, China, 325000
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Wuhan, China, 430030
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Xian, China, 710061
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Zhengzhou, China, 450008
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Zhengzhou, China, 450052
Czechia
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Brno, Czechia, 625 00
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Hradec Kralove, Czechia, 500 05
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Olomouc, Czechia, 779 00
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Ostrava, Czechia, 708 52
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Plzen, Czechia, 304 60
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Praha, Czechia
Denmark
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Aarhus, Denmark, 8200
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Herlev, Denmark, 2730
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Odense C, Denmark, 5000
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Roskilde, Denmark, 4000
France
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Montpellier Cedex 5, France, 34090
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Paris Cedex 10, France, 75475
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Paris, France, 75013
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Paris, France, F-75743 CE
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Pessac, France, 33604
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Pierre Benite, France, 69495
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Rennes Cedex 9, France, 35033
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Rouen Cedex 1, France, 76038
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Toulouse Cedex 9, France, 31059
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Villejuif, France, 94800
Germany
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Hamburg, Germany, 20099
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Köln, Germany, 50924
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Paderborn, Germany, 33098
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Potsdam, Germany, 14467
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Ulm, Germany, 89081
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Würzburg, Germany, 97080
Hungary
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Budapest, Hungary, 1083
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Budapest, Hungary, 1125
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Debrecen, Hungary, 4032
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Kaposvár, Hungary, 7400
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Pécs, Hungary, 7624
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Szeged, Hungary, 6725
Israel
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Dammam, Israel, 31444
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Jerusalem, Israel, 91120
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Jerusalem, Israel
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Petah Tiqva, Israel, 49100
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52620
Italy
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Meldola, Italy, 47014
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Milano, Italy, 20132
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Milano, Italy, 20162
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Ravenna, Italy, 48121
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Torino, Italy, 10126
Korea, Republic of
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Incheon, Korea, Republic of, 21565
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06591
Mexico
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D.F, Mexico, 14050
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Mexico, Mexico, 01710
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Monterrey, Mexico, 64460
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Morelia, Mexico, 58260
Netherlands
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Almere, Netherlands, 1315 RA
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Amsterdam, Netherlands, 1105 AZ
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Arnhem, Netherlands, 6815 AD
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Breda, Netherlands, 4818 CK
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Breda, Netherlands, 4818 CK
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Den Bosch, Netherlands, 5223 GZ
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Nieuwegein, Netherlands, 3435 CM
Poland
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Brzozów, Poland, 36-200
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Bydgoszcz, Poland, 85-168
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Gdynia, Poland, 81-519
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Kraków, Poland, 30-510
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Lublin, Poland, 20-081
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Wrocław, Poland, 50-367
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Wrocław, Poland, 50-556
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Łódź, Poland, 93-510
Russian Federation
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 125284
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Saint Petersburg, Russian Federation, 197347
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Saint-Petersburg, Russian Federation
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Samara, Russian Federation, 443095
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St Petersburg, Russian Federation, 197341
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Tula, Russian Federation, 300053
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Volgograd, Russian Federation, 400138
Saudi Arabia
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Jeddah, Saudi Arabia, 21423
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Riyadh, Saudi Arabia, 12713
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Riyadh, Saudi Arabia, 14611
Slovakia
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Bratislava, Slovakia, 83310
South Africa
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7925
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Johannesburg, South Africa, 2013
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Johannesburg, South Africa, 2196
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Pretoria, South Africa, 0044
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Randburg, South Africa, 2125
Spain
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Badalona(Barcelona), Spain, 08916
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Barcelona, Spain, 08035
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Barcelona, Spain, 08041
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Madrid, Spain, 28007
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Madrid, Spain, 28031
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Madrid, Spain, 28033
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Madrid, Spain, 28041
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Majadahonda, Spain, 28222
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Salamanca, Spain, 37007
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Santander, Spain, 39008
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Valencia, Spain, 46009
Sweden
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Göteborg, Sweden, 41345
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Uppsala, Sweden, 75185
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Örebro, Sweden, 70185
Taiwan
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 404
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Tainan City, Taiwan, 70403
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 11217
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Taoyuan City, Taiwan, 333
Turkey
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Ankara, Turkey, 06100
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Ankara, Turkey
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Izmir, Turkey, 35340
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Kurupelit, Turkey, 55139
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Talas, Turkey, 38280
Ukraine
Research Site Suspended
Cherkasy, Ukraine, 18009
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Dnipro, Ukraine, 49102
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Ivano-Frankivsk, Ukraine
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Kharkiv Region, Ukraine, 61070
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Khmelnytskyi, Ukraine, 29000
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Kyiv, Ukraine, 03022
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Kyiv, Ukraine
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Zhytomyr, Ukraine, 10002
United Kingdom
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Cambridge, United Kingdom, CB2 0QQ
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Canterbury, United Kingdom, CT1 3NG
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Leeds, United Kingdom, LS9 7TF
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Wolverhampton, United Kingdom, WV10 OQP
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT03836261    
Other Study ID Numbers: ACE-CL-311
D8221C00001 ( Other Identifier: AstraZeneca )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acerta Pharma BV:
CLL
Chronic Leukemia Lymphocytic
Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Obinutuzumab
Antineoplastic Agents
Antineoplastic Agents, Immunological