Клинические исследование Chronic Lymphocytic Leukemia: Acalabrutinib, Venetoclax, Chemoimmunotherapy, Obinutuzumab

Спонсоры	Ведущий спонсор: Acerta Pharma BV Коллаборационист: AstraZeneca
Источник	Acerta Pharma BV
Краткое содержание	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.

Спонсоры

Ведущий спонсор: Acerta Pharma BV

Коллаборационист: AstraZeneca

Источник

Acerta Pharma BV

Краткое содержание

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.

Подробное описание

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.

Общий статус

Recruiting

Дата начала

2019-02-25

Дата завершения

2027-01-06

Дата первичного завершения

2027-01-06

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS	6 years

Вторичный результат

Мера	Временное ограничение
To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS	6 years
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.	6 years

Регистрация

780

Состояние	Chronic Lymphocytic Leukemia
Вмешательство	Тип вмешательства: Drug Название вмешательства: Acalabrutinib Описание: Acalabrutinib, Другое имя: Calquence (acalabrutinib) Тип вмешательства: Drug Название вмешательства: Venetoclax Описание: Venetoclax Другое имя: Venclyxto, Venclexta Тип вмешательства: Drug Название вмешательства: Chemoimmunotherapy Описание: fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR) Этикетка Arm Group: Chemoimmunotherapy Тип вмешательства: Drug Название вмешательства: Obinutuzumab Описание: Obinutuzumab Этикетка Arm Group: Acalabrutinib, Venetoclax, Obinutuzumab Другое имя: Gazyva, Gazyvaro
Приемлемость	Критерии: 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. Пол: All Минимальный возраст: 18 Years Максимальный возраст: 130 Years Здоровые волонтеры: No

Состояние

Chronic Lymphocytic Leukemia

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Acalabrutinib

Описание: Acalabrutinib,

Другое имя: Calquence (acalabrutinib)

Тип вмешательства: Drug

Название вмешательства: Venetoclax

Описание: Venetoclax

Другое имя: Venclyxto, Venclexta

Тип вмешательства: Drug

Название вмешательства: Chemoimmunotherapy

Описание: fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)

Этикетка Arm Group: Chemoimmunotherapy

Тип вмешательства: Drug

Название вмешательства: Obinutuzumab

Описание: Obinutuzumab

Этикетка Arm Group: Acalabrutinib, Venetoclax, Obinutuzumab

Другое имя: Gazyva, Gazyvaro

Приемлемость

Критерии:

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.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

130 Years

Здоровые волонтеры:

Общий контакт

Фамилия: AstraZeneca Clinical Study Information Center

Телефон: 1-877-240-9479

Расположение

Объект:	Положение дел:
Research Site \| Fountain Valley, California, 92708, United States	Withdrawn
Research Site \| Fullerton, California, 92835, United States	Withdrawn
Research Site \| Los Angeles, California, 90095, United States	Active, not recruiting
Research Site \| Redondo Beach, California, 90277, United States	Completed
Research Site \| Santa Barbara, California, 93105, United States	Withdrawn
Research Site \| Orlando, Florida, 32806, United States	Withdrawn
Research Site \| Fort Wayne, Indiana, 46804, United States	Active, not recruiting
Research Site \| Wichita, Kansas, 67214, United States	Active, not recruiting
Research Site \| Louisville, Kentucky, 40207, United States	Active, not recruiting
Research Site \| New Orleans, Louisiana, 70056, United States	Active, not recruiting
Research Site \| Baltimore, Maryland, 21201, United States	Active, not recruiting
Research Site \| Boston, Massachusetts, 02215, United States	Active, not recruiting
Research Site \| Boston, Massachusetts, 02215, United States	Withdrawn
Research Site \| Brick, New Jersey, 08724, United States	Withdrawn
Research Site \| Florham Park, New Jersey, 07932, United States	Withdrawn
Research Site \| New York, New York, 10021, United States	Completed
Research Site \| New York, New York, 10029, United States	Withdrawn
Research Site \| New York, New York, 10032, United States	Withdrawn
Research Site \| Charlotte, North Carolina, 28204, United States	Active, not recruiting
Research Site \| Canton, Ohio, 44718, United States	Active, not recruiting
Research Site \| Pittsburgh, Pennsylvania, 15224, United States	Active, not recruiting
Research Site \| Pittsburgh, Pennsylvania, 15232, United States	Active, not recruiting
Research Site \| Fort Sam Houston, Texas, 78234, United States	Active, not recruiting
Research Site \| Spokane, Washington, 99208, United States	Active, not recruiting
Research Site \| Tacoma, Washington, 98405, United States	Active, not recruiting
Research Site \| Madison, Wisconsin, 53792, United States	Withdrawn
Research Site \| Buenos Aires, 1114, Argentina	Active, not recruiting
Research Site \| Buenos Aires, C1426ANZ, Argentina	Active, not recruiting
Research Site \| Capital Federal, 1118, Argentina	Active, not recruiting
Research Site \| Ciudad Autonoma Buenos Aires, C1181ACH, Argentina	Not yet recruiting
Research Site \| Córdoba, 5000, Argentina	Terminated
Research Site \| Córdoba, X5016KEH, Argentina	Withdrawn
Research Site \| Adelaide, 5000, Australia	Active, not recruiting
Research Site \| Darlinghurst, 2010, Australia	Active, not recruiting
Research Site \| Heidelberg, 3084, Australia	Active, not recruiting
Research Site \| Kogarah, 2217, Australia	Active, not recruiting
Research Site \| Melbourne, 3000, Australia	Active, not recruiting
Research Site \| Nedlands, 6009, Australia	Active, not recruiting
Research Site \| Waratah, 2298, Australia	Active, not recruiting
Research Site \| Woolloongabba, 4102, Australia	Active, not recruiting
Research Site \| Krems, 3500, Austria	Recruiting
Research Site \| Salzburg, 5020, Austria	Active, not recruiting
Research Site \| Vienna, 1140, Austria	Active, not recruiting
Research Site \| Yvoir, 5530, Belgium	Withdrawn
Research Site \| Curitiba, 80060-900, Brazil	Withdrawn
Research Site \| Curitiba, 81520-060, Brazil	Withdrawn
Research Site \| Goiania, 74605-020, Brazil	Active, not recruiting
Research Site \| Hangzhou, 310003, Brazil	Recruiting
Research Site \| Mexico City, 02990, Brazil	Withdrawn
Research Site \| Monterrey, 64570, Brazil	Withdrawn
Research Site \| Porto Alegre, 90020-090, Brazil	Terminated
Research Site \| Porto Alegre, 90035-003, Brazil	Active, not recruiting
Research Site \| Porto Alegre, 90110-270, Brazil	Active, not recruiting
Research Site \| Rio de Janeiro, 20230-130, Brazil	Active, not recruiting
Research Site \| Rio de Janeiro, 22793-080, Brazil	Terminated
Research Site \| Sao Paulo, 01236-030, Brazil	Active, not recruiting
Research Site \| Sao Paulo, 01509-900, Brazil	Withdrawn
Research Site \| Sao Paulo, 04121-000, Brazil	Withdrawn
Research Site \| Sao Paulo, 05403-010, Brazil	Active, not recruiting
Research Site \| São José do Rio Preto, 15090-000, Brazil	Withdrawn
Research Site \| São Paulo, 01308-050, Brazil	Active, not recruiting
Research Site \| Pleven, Bulgaria	Withdrawn
Research Site \| Plovdiv, Bulgaria	Active, not recruiting
Research Site \| Sofia, 1606, Bulgaria	Withdrawn
Research Site \| Sofia, 1606, Bulgaria	Active, not recruiting
Research Site \| Vratsa, 3000, Bulgaria	Active, not recruiting
Research Site \| Calgary, Alberta, T2N 4N2, Canada	Active, not recruiting
Research Site \| Edmonton, Alberta, T6G 1Z2, Canada	Active, not recruiting
Research Site \| Vancouver, British Columbia, V5Z 4E6, Canada	Active, not recruiting
Research Site \| Ottawa, Ontario, K1H 8L6, Canada	Active, not recruiting
Research Site \| Toronto, Ontario, M4N 3M5, Canada	Active, not recruiting
Research Site \| Toronto, Ontario, M5G 2M9, Canada	Active, not recruiting
Research Site \| Montreal, Quebec, H4J 1C5, Canada	Active, not recruiting
Research Site \| Quebec, G1J 1Z4, Canada	Active, not recruiting
Research Site \| Beijing, 100034, China	Not yet recruiting
Research Site \| Beijing, 100044, China	Recruiting
Research Site \| Beijing, 100191, China	Not yet recruiting
Research Site \| Changchun, 130021, China	Not yet recruiting
Research Site \| Changsha, 410008, China	Not yet recruiting
Research Site \| Chengdu, 610041, China	Not yet recruiting
Research Site \| Chongqing, 400037, China	Not yet recruiting
Research Site \| Fuzhou, 350009, China	Not yet recruiting
Research Site \| Guangzhou, 510100, China	Not yet recruiting
Research Site \| Guangzhou, 510515, China	Recruiting
Research Site \| Haikou, 570311, China	Not yet recruiting
Research Site \| Jinan, 250012, China	Withdrawn
Research Site \| Lanzhou, 730050, China	Withdrawn
Research Site \| Nanchang, 330006, China	Not yet recruiting
Research Site \| Nanjing, 210029, China	Recruiting
Research Site \| Shanghai, 200025, China	Not yet recruiting
Research Site \| Shenyang, 110001, China	Not yet recruiting
Research Site \| Shenzhen, 518039, China	Not yet recruiting
Research Site \| Tianjin, 300020, China	Not yet recruiting
Research Site \| Urumchi, 830054, China	Not yet recruiting
Research Site \| Wenzhou, 325000, China	Not yet recruiting
Research Site \| Wuhan, 430022, China	Recruiting
Research Site \| Wuhan, 430030, China	Not yet recruiting
Research Site \| Xian, 710061, China	Not yet recruiting
Research Site \| Zhengzhou, 450008, China	Recruiting
Research Site \| Zhengzhou, 450052, China	Not yet recruiting
Research Site \| Brno, 625 00, Czechia	Active, not recruiting
Research Site \| Hradec Kralove, 500 05, Czechia	Active, not recruiting
Research Site \| Olomouc, 779 00, Czechia	Active, not recruiting
Research Site \| Ostrava, 708 52, Czechia	Active, not recruiting
Research Site \| Plzen, 304 60, Czechia	Active, not recruiting
Research Site \| Praha 1, 128 00, Czechia	Withdrawn
Research Site \| Praha, Czechia	Terminated
Research Site \| Aarhus, 8200, Denmark	Active, not recruiting
Research Site \| Herlev, 2730, Denmark	Active, not recruiting
Research Site \| Odense C, 5000, Denmark	Active, not recruiting
Research Site \| Roskilde, 4000, Denmark	Active, not recruiting
Research Site \| Montpellier Cedex 5, 34090, France	Active, not recruiting
Research Site \| Paris Cedex 10, 75475, France	Active, not recruiting
Research Site \| Paris, 75013, France	Active, not recruiting
Research Site \| Paris, 75015, France	Active, not recruiting
Research Site \| Pessac, 33604, France	Withdrawn
Research Site \| Pierre Benite, 69495, France	Withdrawn
Research Site \| Rennes Cedex 9, 35033, France	Active, not recruiting
Research Site \| Rouen Cedex 1, 76038, France	Active, not recruiting
Research Site \| Toulouse Cedex 9, 31059, France	Active, not recruiting
Research Site \| Villejuif, 94800, France	Active, not recruiting
Research Site \| Erlangen, 91052, Germany	Withdrawn
Research Site \| Hamburg, 20099, Germany	Withdrawn
Research Site \| Köln, 50924, Germany	Active, not recruiting
Research Site \| Paderborn, 33098, Germany	Completed
Research Site \| Potsdam, 14467, Germany	Withdrawn
Research Site \| Ulm, 89081, Germany	Not yet recruiting
Research Site \| Würzburg, 97080, Germany	Active, not recruiting
Research Site \| Budapest, 1083, Hungary	Active, not recruiting
Research Site \| Budapest, 1125, Hungary	Active, not recruiting
Research Site \| Debrecen, 4032, Hungary	Active, not recruiting
Research Site \| Kaposvár, 7400, Hungary	Active, not recruiting
Research Site \| Pécs, 7624, Hungary	Withdrawn
Research Site \| Szeged, 6725, Hungary	Withdrawn
Research Site \| Dammam, 31444, Israel	Active, not recruiting
Research Site \| Haifa, 31048, Israel	Withdrawn
Research Site \| Haifa, 31999, Israel	Active, not recruiting
Research Site \| Jerusalem, 91120, Israel	Active, not recruiting
Research Site \| Jerusalem, Israel	Active, not recruiting
Research Site \| Petah Tiqva, 49100, Israel	Active, not recruiting
Research Site \| Tel Aviv, 64239, Israel	Active, not recruiting
Research Site \| Tel Hashomer, 52620, Israel	Active, not recruiting
Research Site \| Cagliari, 09121, Italy	Withdrawn
Research Site \| Meldola, 47014, Italy	Active, not recruiting
Research Site \| Milano, 20132, Italy	Active, not recruiting
Research Site \| Milano, 20162, Italy	Active, not recruiting
Research Site \| Novara, 28100, Italy	Active, not recruiting
Research Site \| Ravenna, 48121, Italy	Active, not recruiting
Research Site \| Roma, 00161, Italy	Withdrawn
Research Site \| Torino, 10126, Italy	Active, not recruiting
Research Site \| Incheon, 21565, Korea, Republic of	Terminated
Research Site \| Seoul, 03080, Korea, Republic of	Active, not recruiting
Research Site \| Seoul, 03722, Korea, Republic of	Terminated
Research Site \| Seoul, 05505, Korea, Republic of	Active, not recruiting
Research Site \| Seoul, 06591, Korea, Republic of	Active, not recruiting
Research Site \| D.F, 14050, Mexico	Withdrawn
Research Site \| Mexico, 01710, Mexico	Withdrawn
Research Site \| Monterrey, 64460, Mexico	Withdrawn
Research Site \| Morelia, 58260, Mexico	Withdrawn
Research Site \| Almere, 1315 RA, Netherlands	Active, not recruiting
Research Site \| Amsterdam, 1105 AZ, Netherlands	Active, not recruiting
Research Site \| Arnhem, 6815 AD, Netherlands	Active, not recruiting
Research Site \| Breda, 4818 CK, Netherlands	Active, not recruiting
Research Site \| Den Bosch, 5223 GZ, Netherlands	Active, not recruiting
Research Site \| Nieuwegein, 3435 CM, Netherlands	Withdrawn
Research Site \| Lima, LIMA 41, Peru	Withdrawn
Research Site \| Brzozów, 36-200, Poland	Active, not recruiting
Research Site \| Bydgoszcz, 85-168, Poland	Active, not recruiting
Research Site \| Gdynia, 81-519, Poland	Active, not recruiting
Research Site \| Kraków, 30-510, Poland	Active, not recruiting
Research Site \| Lublin, 20-081, Poland	Active, not recruiting
Research Site \| Wrocław, 50-367, Poland	Active, not recruiting
Research Site \| Wrocław, 50-556, Poland	Active, not recruiting
Research Site \| Łódź, 93-510, Poland	Active, not recruiting
Research Site \| Moscow, 115478, Russian Federation	Active, not recruiting
Research Site \| Moscow, 125284, Russian Federation	Active, not recruiting
Research Site \| Moscow, 125284, Russian Federation	Withdrawn
Research Site \| Saint Petersburg, 197347, Russian Federation	Active, not recruiting
Research Site \| Saint-Petersburg, Russian Federation	Active, not recruiting
Research Site \| Samara, 443095, Russian Federation	Active, not recruiting
Research Site \| Sochi, 354057, Russian Federation	Completed
Research Site \| St Petersburg, 197341, Russian Federation	Active, not recruiting
Research Site \| Tula, 300053, Russian Federation	Recruiting
Research Site \| Volgograd, 400138, Russian Federation	Active, not recruiting
Research Site \| Jeddah, 21423, Saudi Arabia	Active, not recruiting
Research Site \| Riyadh, 12713, Saudi Arabia	Active, not recruiting
Research Site \| Riyadh, 14611, Saudi Arabia	Withdrawn
Research Site \| Bratislava, 83310, Slovakia	Active, not recruiting
Research Site \| Bratislava, 85107, Slovakia	Withdrawn
Research Site \| Bloemfontein, 9301, South Africa	Active, not recruiting
Research Site \| Cape Town, 7925, South Africa	Active, not recruiting
Research Site \| Johannesburg, 2013, South Africa	Active, not recruiting
Research Site \| Johannesburg, 2196, South Africa	Withdrawn
Research Site \| Pretoria, 0044, South Africa	Active, not recruiting
Research Site \| Randburg, 2125, South Africa	Active, not recruiting
Research Site \| Badalona(Barcelona), 08916, Spain	Active, not recruiting
Research Site \| Barcelona, 08035, Spain	Active, not recruiting
Research Site \| Barcelona, 08041, Spain	Active, not recruiting
Research Site \| Madrid, 28006, Spain	Withdrawn
Research Site \| Madrid, 28007, Spain	Active, not recruiting
Research Site \| Madrid, 28031, Spain	Active, not recruiting
Research Site \| Madrid, 28033, Spain	Withdrawn
Research Site \| Madrid, 28041, Spain	Withdrawn
Research Site \| Majadahonda, 28222, Spain	Active, not recruiting
Research Site \| Salamanca, 37007, Spain	Terminated
Research Site \| Santander, 39008, Spain	Active, not recruiting
Research Site \| Valencia, 46009, Spain	Terminated
Research Site \| Göteborg, 41345, Sweden	Active, not recruiting
Research Site \| Uppsala, 75185, Sweden	Active, not recruiting
Research Site \| Örebro, 70185, Sweden	Active, not recruiting
Research Site \| Kaohsiung, 833, Taiwan	Active, not recruiting
Research Site \| Taichung, 404, Taiwan	Terminated
Research Site \| Tainan City, 70403, Taiwan	Active, not recruiting
Research Site \| Taipei, 10002, Taiwan	Active, not recruiting
Research Site \| Taipei, 11217, Taiwan	Active, not recruiting
Research Site \| Taoyuan City, 333, Taiwan	Recruiting
Research Site \| Ankara, 06100, Turkey	Active, not recruiting
Research Site \| Ankara, Turkey	Active, not recruiting
Research Site \| Izmir, 35340, Turkey	Active, not recruiting
Research Site \| Kurupelit, 55139, Turkey	Active, not recruiting
Research Site \| Talas, 38280, Turkey	Active, not recruiting
Research Site \| Trabzon, 61100, Turkey	Withdrawn
Research Site \| Cherkasy, 18009, Ukraine	Withdrawn
Research Site \| Dnipro, 49102, Ukraine	Withdrawn
Research Site \| Ivano-Frankivsk, Ukraine	Withdrawn
Research Site \| Kharkiv Region, 61070, Ukraine	Withdrawn
Research Site \| Khmelnytskyi, 29000, Ukraine	Withdrawn
Research Site \| Kyiv, 03022, Ukraine	Withdrawn
Research Site \| Kyiv, Ukraine	Withdrawn
Research Site \| Zhytomyr, 10002, Ukraine	Withdrawn
Research Site \| Cambridge, CB2 0QQ, United Kingdom	Active, not recruiting
Research Site \| Canterbury, CT1 3NG, United Kingdom	Active, not recruiting
Research Site \| Leeds, LS9 7TF, United Kingdom	Withdrawn
Research Site \| Wolverhampton, WV10 OQP, United Kingdom	Active, not recruiting

Расположение Страны	Argentina Australia Austria Belgium Brazil Bulgaria Canada China Czechia Denmark France Germany Hungary Israel Italy Korea, Republic of Mexico Netherlands Peru Poland Russian Federation Saudi Arabia Slovakia South Africa Spain Sweden Taiwan Turkey Ukraine United Kingdom United States
Дата проверки	2021-12-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	CLL Chronic Leukemia Lymphocytic Leukemia
Имеет расширенный доступ	No
Состояние Просмотр	Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell
Количество рук	3
Группа вооружений	Метка: Acalabrutinib, Venetoclax Тип: Experimental Описание: Acalabrutinib in combination with Venetoclax Метка: Acalabrutinib, Venetoclax, Obinutuzumab Тип: Experimental Описание: Acalabrutinib in combination with Venetoclax with or without Obinutuzumab Метка: Chemoimmunotherapy Тип: Active Comparator Описание: Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: None (Open Label)

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