Chronic Lymphocytic Leukemia Clinical Trial

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

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 leukemia-cll/" >CLL

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

984

Study ID:

NCT03836261

Recruitment Status:

Active, not recruiting

Sponsor:

Acerta Pharma BV

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There are 161 Locations for this study

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Los Angeles California, 90095, United States
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Redondo Beach California, 90277, United States
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Fort Wayne Indiana, 46804, United States
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Wichita Kansas, 67214, United States
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Louisville Kentucky, 40207, United States
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New Orleans Louisiana, 70056, United States
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Baltimore Maryland, 21201, United States
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Boston Massachusetts, 02215, United States
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New York New York, 10021, United States
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Charlotte North Carolina, 28204, United States
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Canton Ohio, 44718, United States
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Pittsburgh Pennsylvania, 15224, United States
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Pittsburgh Pennsylvania, 15232, United States
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Fort Sam Houston Texas, 78234, United States
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Spokane Washington, 99208, United States
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Tacoma Washington, 98405, United States
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Buenos Aires , 1114, Argentina
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Buenos Aires , C1426, Argentina
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Capital Federal , 1118, Argentina
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Córdoba , 5000, Argentina
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Adelaide , 5000, Australia
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Darlinghurst , 2010, Australia
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Heidelberg , 3084, Australia
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Kogarah , 2217, Australia
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Melbourne , 3000, Australia
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Nedlands , 6009, Australia
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Waratah , 2298, Australia
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Woolloongabba , 4102, Australia
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Krems , 3500, Austria
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Salzburg , 5020, Austria
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Vienna , 1140, Austria
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Goiania , 74605, Brazil
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Porto Alegre , 90020, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90110, Brazil
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Rio de Janeiro , 20230, Brazil
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Rio de Janeiro , 22793, Brazil
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Sao Paulo , 01236, Brazil
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Sao Paulo , 05403, Brazil
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São Paulo , 01308, Brazil
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Plovdiv , , Bulgaria
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Sofia , 1606, Bulgaria
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Vratsa , 3000, Bulgaria
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H4J 1, Canada
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Quebec , G1J 1, Canada
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Beijing , 10003, China
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Beijing , 10004, China
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Beijing , 10019, China
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Changchun , 13002, China
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Changsha , 41000, China
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Chengdu , 61004, China
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Chongqing , 40003, China
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Guangzhou , 51010, China
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Guangzhou , 51051, China
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Hangzhou , 31000, China
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Nanchang , 33000, China
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Nanjing , 21002, China
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Shengyang , 11000, China
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Shenyang , 11000, China
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Shenyang , 11000, China
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Tianjin , 30002, China
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Urumchi , 83005, China
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Wenzhou , 32500, China
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Wuhan , 43002, China
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Wuhan , 43003, China
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Xian , 71006, China
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Zhengzhou , 45000, China
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Zhengzhou , 45005, China
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Brno , 625 0, Czechia
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Hradec Kralove , 500 0, Czechia
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Olomouc , 779 0, Czechia
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Ostrava , 708 5, Czechia
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Plzen , 304 6, Czechia
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Praha , , Czechia
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Aarhus , 8200, Denmark
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Copenhagen , 2100, Denmark
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Roskilde , 4000, Denmark
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Montpellier Cedex 5 , 34090, France
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Paris Cedex 10 , 75475, France
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Paris , 75013, France
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Paris , 75015, France
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Rennes Cedex 9 , 35033, France
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Rouen Cedex 1 , 76038, France
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Toulouse Cedex 9 , 31059, France
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Villejuif , 94800, France
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Paderborn , 33098, Germany
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Würzburg , 97080, Germany
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Budapest , 1083, Hungary
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Budapest , 1125, Hungary
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Debrecen , 4032, Hungary
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Kaposvár , 7400, Hungary
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Haifa , 31999, Israel
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Jerusalem , 91120, Israel
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Jerusalem , , Israel
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Petah Tiqva , 49100, Israel
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Tel Aviv , 64239, Israel
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Tel Hashomer , 52620, Israel
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Meldola , 47014, Italy
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Milano , 20132, Italy
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Milano , 20162, Italy
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Novara , 28100, Italy
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Ravenna , 48121, Italy
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Torino , 10126, Italy
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Incheon , 21565, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Almere , 1315 , Netherlands
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Amsterdam , 1105 , Netherlands
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Arnhem , 6815 , Netherlands
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Breda , 4818 , Netherlands
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Den Bosch , 5223 , Netherlands
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Brzozów , 36-20, Poland
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Bydgoszcz , 85-16, Poland
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Gdynia , 81-51, Poland
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Krakow , 30-72, Poland
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Lublin , 20-08, Poland
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Wrocław , 50-36, Poland
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Wrocław , 50-55, Poland
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Łódź , 93-51, Poland
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Moscow , 11547, Russian Federation
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Moscow , 12528, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Saint-Petersburg , , Russian Federation
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Samara , 44309, Russian Federation
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Sochi , 35405, Russian Federation
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St Petersburg , 19734, Russian Federation
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Tula , 30005, Russian Federation
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Volgograd , 40013, Russian Federation
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Dammam , 31444, Saudi Arabia
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Jeddah , 21423, Saudi Arabia
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Riyadh , 12713, Saudi Arabia
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Bratislava , 83310, Slovakia
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Bloemfontein , 9301, South Africa
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Cape Town , 7925, South Africa
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Johannesburg , 2013, South Africa
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Pretoria , 0044, South Africa
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Randburg , 2125, South Africa
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Badalona(Barcelona) , 08916, Spain
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Barcelona , 08035, Spain
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Barcelona , 08041, Spain
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Madrid , 28007, Spain
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Madrid , 28031, Spain
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Majadahonda , 28222, Spain
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Salamanca , 37007, Spain
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Santander , 39008, Spain
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Valencia , 46009, Spain
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Göteborg , 41345, Sweden
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Uppsala , 75185, Sweden
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Örebro , 70185, Sweden
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Kaohsiung , 833, Taiwan
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Taichung , 404, Taiwan
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Tainan City , 70403, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11217, Taiwan
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Taoyuan City , 333, Taiwan
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Ankara , 06100, Turkey
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Ankara , , Turkey
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Izmir , 35340, Turkey
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Kurupelit , 55139, Turkey
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Talas , 38280, Turkey
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Cambridge , CB2 0, United Kingdom
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Canterbury , CT1 3, United Kingdom
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Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

984

Study ID:

NCT03836261

Recruitment Status:

Active, not recruiting

Sponsor:


Acerta Pharma BV

How clear is this clinincal trial information?

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