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:

780

Study ID:

NCT03836261

Recruitment Status:

Recruiting

Sponsor:

Acerta Pharma BV

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 188 Locations for this study

See Locations Near You

Research Site
Fountain Valley California, 92708, United States
Research Site
Fullerton California, 92835, United States
Research Site
Los Angeles California, 90095, United States
Research Site
Redondo Beach California, 90277, United States
Research Site
Santa Barbara California, 93105, United States
Research Site
Orlando Florida, 32806, United States
Research Site
Fort Wayne Indiana, 46804, United States
Research Site
Wichita Kansas, 67214, United States
Research Site
Louisville Kentucky, 40207, United States
Research Site
New Orleans Louisiana, 70056, United States
Research Site
Baltimore Maryland, 21201, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
New York New York, 10021, United States
Research Site
New York New York, 10032, United States
Research Site
Charlotte North Carolina, 28204, United States
Research Site
Canton Ohio, 44718, United States
Research Site
Pittsburgh Pennsylvania, 15224, United States
Research Site
Pittsburgh Pennsylvania, 15232, United States
Research Site
Fort Sam Houston Texas, 78234, United States
Research Site
Spokane Washington, 99208, United States
Research Site
Tacoma Washington, 98405, United States
Research Site
Buenos Aires , 1114, Argentina
Research Site
Buenos Aires , C1426, Argentina
Research Site
Capital Federal , 1118, Argentina
Research Site
Córdoba , 5000, Argentina
Research Site
Adelaide , 5000, Australia
Research Site
Darlinghurst , 2010, Australia
Research Site
Heidelberg , 3084, Australia
Research Site
Kogarah , 2217, Australia
Research Site
Melbourne , 3000, Australia
Research Site
Nedlands , 6009, Australia
Research Site
Waratah , 2298, Australia
Research Site
Woolloongabba , 4102, Australia
Research Site
Krems , 3500, Austria
Research Site
Salzburg , 5020, Austria
Research Site
Vienna , 1140, Austria
Research Site
Goiania , 74605, Brazil
Research Site
Porto Alegre , 90020, Brazil
Research Site
Porto Alegre , 90035, Brazil
Research Site
Porto Alegre , 90110, Brazil
Research Site
Rio de Janeiro , 20230, Brazil
Research Site
Rio de Janeiro , 22793, Brazil
Research Site
Sao Paulo , 01236, Brazil
Research Site
Sao Paulo , 01509, Brazil
Research Site
Sao Paulo , 05403, Brazil
Research Site
São Paulo , 01308, Brazil
Research Site
Plovdiv , , Bulgaria
Research Site
Sofia , 1606, Bulgaria
Research Site
Sofia , 1606, Bulgaria
Research Site
Vratsa , 3000, Bulgaria
Research Site
Calgary Alberta, T2N 4, Canada
Research Site
Edmonton Alberta, T6G 1, Canada
Research Site
Vancouver British Columbia, V5Z 4, Canada
Research Site
Ottawa Ontario, K1H 8, Canada
Research Site
Toronto Ontario, M4N 3, Canada
Research Site
Toronto Ontario, M5G 2, Canada
Research Site
Montreal Quebec, H4J 1, Canada
Research Site
Quebec , G1J 1, Canada
Research Site
Beijing , 10003, China
Research Site
Beijing , 10004, China
Research Site
Beijing , 10019, China
Research Site
Changchun , 13002, China
Research Site
Changsha , 41000, China
Research Site
Chengdu , 61004, China
Research Site
Chongqing , 40003, China
Research Site
Fuzhou , 35000, China
Research Site
Guangzhou , 51010, China
Research Site
Guangzhou , 51051, China
Research Site
Haikou , 57031, China
Research Site
Hangzhou , 31000, China
Research Site
Nanchang , 33000, China
Research Site
Nanjing , 21002, China
Research Site
Shanghai , 20002, China
Research Site
Shenyang , 11000, China
Research Site
Shenzhen , 51803, China
Research Site
Tianjin , 30002, China
Research Site
Urumchi , 83005, China
Research Site
Wenzhou , 32500, China
Research Site
Wuhan , 43002, China
Research Site
Wuhan , 43003, China
Research Site
Xian , 71006, China
Research Site
Zhengzhou , 45000, China
Research Site
Zhengzhou , 45005, China
Research Site
Brno , 625 0, Czechia
Research Site
Hradec Kralove , 500 0, Czechia
Research Site
Olomouc , 779 0, Czechia
Research Site
Ostrava , 708 5, Czechia
Research Site
Plzen , 304 6, Czechia
Research Site
Praha , , Czechia
Research Site
Aarhus , 8200, Denmark
Research Site
Copenhagen , 2100, Denmark
Research Site
Odense C , 5000, Denmark
Research Site
Roskilde , 4000, Denmark
Research Site
Montpellier Cedex 5 , 34090, France
Research Site
Paris Cedex 10 , 75475, France
Research Site
Paris , 75013, France
Research Site
Paris , 75015, France
Research Site
Pessac , 33604, France
Research Site
Pierre Benite , 69495, France
Research Site
Rennes Cedex 9 , 35033, France
Research Site
Rouen Cedex 1 , 76038, France
Research Site
Toulouse Cedex 9 , 31059, France
Research Site
Villejuif , 94800, France
Research Site
Hamburg , 20099, Germany
Research Site
Köln , 50924, Germany
Research Site
Paderborn , 33098, Germany
Research Site
Potsdam , 14467, Germany
Research Site
Würzburg , 97080, Germany
Research Site
Budapest , 1083, Hungary
Research Site
Budapest , 1125, Hungary
Research Site
Debrecen , 4032, Hungary
Research Site
Kaposvár , 7400, Hungary
Research Site
Haifa , 31999, Israel
Research Site
Jerusalem , 91120, Israel
Research Site
Jerusalem , , Israel
Research Site
Petah Tiqva , 49100, Israel
Research Site
Tel Aviv , 64239, Israel
Research Site
Tel Hashomer , 52620, Israel
Research Site
Meldola , 47014, Italy
Research Site
Milano , 20132, Italy
Research Site
Milano , 20162, Italy
Research Site
Novara , 28100, Italy
Research Site
Ravenna , 48121, Italy
Research Site
Torino , 10126, Italy
Research Site
Incheon , 21565, Korea, Republic of
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
Research Site
Seoul , 06591, Korea, Republic of
Research Site
D.F , 14050, Mexico
Research Site
Mexico , 01710, Mexico
Research Site
Monterrey , 64460, Mexico
Research Site
Monterrey , 64570, Mexico
Research Site
Morelia , 58260, Mexico
Research Site
Almere , 1315 , Netherlands
Research Site
Amsterdam , 1105 , Netherlands
Research Site
Arnhem , 6815 , Netherlands
Research Site
Breda , 4818 , Netherlands
Research Site
Den Bosch , 5223 , Netherlands
Research Site
Nieuwegein , 3435 , Netherlands
Research Site
Brzozów , 36-20, Poland
Research Site
Bydgoszcz , 85-16, Poland
Research Site
Gdynia , 81-51, Poland
Research Site
Kraków , 30-51, Poland
Research Site
Lublin , 20-08, Poland
Research Site
Wrocław , 50-36, Poland
Research Site
Wrocław , 50-55, Poland
Research Site
Łódź , 93-51, Poland
Research Site
Moscow , 11547, Russian Federation
Research Site
Moscow , 12528, Russian Federation
Research Site
Saint Petersburg , 19734, Russian Federation
Research Site
Saint-Petersburg , , Russian Federation
Research Site
Samara , 44309, Russian Federation
Research Site
Sochi , 35405, Russian Federation
Research Site
St Petersburg , 19734, Russian Federation
Research Site
Tula , 30005, Russian Federation
Research Site
Volgograd , 40013, Russian Federation
Research Site
Dammam , 31444, Saudi Arabia
Research Site
Jeddah , 21423, Saudi Arabia
Research Site
Riyadh , 12713, Saudi Arabia
Research Site
Riyadh , 14611, Saudi Arabia
Research Site
Bratislava , 83310, Slovakia
Research Site
Bloemfontein , 9301, South Africa
Research Site
Cape Town , 7925, South Africa
Research Site
Johannesburg , 2013, South Africa
Research Site
Pretoria , 0044, South Africa
Research Site
Randburg , 2125, South Africa
Research Site
Badalona(Barcelona) , 08916, Spain
Research Site
Barcelona , 08035, Spain
Research Site
Barcelona , 08041, Spain
Research Site
Madrid , 28007, Spain
Research Site
Madrid , 28031, Spain
Research Site
Majadahonda , 28222, Spain
Research Site
Salamanca , 37007, Spain
Research Site
Santander , 39008, Spain
Research Site
Valencia , 46009, Spain
Research Site
Göteborg , 41345, Sweden
Research Site
Uppsala , 75185, Sweden
Research Site
Örebro , 70185, Sweden
Research Site
Kaohsiung , 833, Taiwan
Research Site
Taichung , 404, Taiwan
Research Site
Tainan City , 70403, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Taipei , 11217, Taiwan
Research Site
Taoyuan City , 333, Taiwan
Research Site
Ankara , 06100, Turkey
Research Site
Ankara , , Turkey
Research Site
Izmir , 35340, Turkey
Research Site
Kurupelit , 55139, Turkey
Research Site
Talas , 38280, Turkey
Research Site
Cherkasy , 18009, Ukraine
Research Site
Dnipro , 49102, Ukraine
Research Site
Ivano-Frankivsk , , Ukraine
Research Site
Kharkiv Region , 61070, Ukraine
Research Site
Khmelnytskyi , 29000, Ukraine
Research Site
Kyiv , 03022, Ukraine
Research Site
Kyiv , , Ukraine
Research Site
Zhytomyr , 10002, Ukraine
Research Site
Cambridge , CB2 0, United Kingdom
Research Site
Canterbury , CT1 3, United Kingdom
Research Site
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

780

Study ID:

NCT03836261

Recruitment Status:

Recruiting

Sponsor:


Acerta Pharma BV

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.