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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

Primary Purpose

Chronic Lymphocytic Leukemia

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Acalabrutinib

Venetoclax

Chemoimmunotherapy

Obinutuzumab

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, Chronic Leukemia Lymphocytic, Leukemia

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Acalabrutinib, Venetoclax

Acalabrutinib, Venetoclax, Obinutuzumab

Chemoimmunotherapy

Arm Description

Acalabrutinib in combination with Venetoclax

Acalabrutinib in combination with Venetoclax with or without Obinutuzumab

Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab

Outcomes

Primary Outcome Measures

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

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

To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS

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

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.

Full Information

NCT ID

NCT03836261

First Posted

February 6, 2019

Last Updated

July 19, 2023

Sponsor

Acerta Pharma BV

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03836261

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 25, 2019 (Actual)

Primary Completion Date

January 6, 2027 (Anticipated)

Study Completion Date

January 6, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acerta Pharma BV

Collaborators

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

Keywords

CLL, Chronic Leukemia Lymphocytic, Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

780 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acalabrutinib, Venetoclax

Arm Type

Experimental

Arm Description

Acalabrutinib in combination with Venetoclax

Arm Title

Acalabrutinib, Venetoclax, Obinutuzumab

Arm Type

Experimental

Arm Description

Acalabrutinib in combination with Venetoclax with or without Obinutuzumab

Arm Title

Chemoimmunotherapy

Arm Type

Active Comparator

Arm Description

Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab

Intervention Type

Drug

Intervention Name(s)

Acalabrutinib

Other Intervention Name(s)

Calquence (acalabrutinib)

Intervention Description

Acalabrutinib,

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Other Intervention Name(s)

Venclyxto, Venclexta

Intervention Description

Venetoclax

Intervention Type

Drug

Intervention Name(s)

Chemoimmunotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Obinutuzumab

Other Intervention Name(s)

Gazyva, Gazyvaro

Intervention Description

Obinutuzumab

Primary Outcome Measure Information:

Title

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

Description

Time Frame

6 years

Secondary Outcome Measure Information:

Title

To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS

Description

Time Frame

6 years

Title

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.

Description

Time Frame

6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

AstraZeneca Clinical Study Information Center

Phone

1-877-240-9479

information.center@astrazeneca.com

Facility Information:

Facility Name

Research Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Individual Site Status

Completed

Facility Name

Research Site

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70056

Country

United States

Individual Site Status

Completed

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Individual Site Status

Completed

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

1114

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Capital Federal

ZIP/Postal Code

1118

Country

Argentina

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

5000

Country

Argentina

Individual Site Status

Terminated

Facility Name

Research Site

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Heidelberg

ZIP/Postal Code

3084

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Melbourne

ZIP/Postal Code

3000

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Waratah

ZIP/Postal Code

2298

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Krems

ZIP/Postal Code

3500

Country

Austria

Individual Site Status

Terminated

Facility Name

Research Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Vienna

ZIP/Postal Code

1140

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Goiania

ZIP/Postal Code

74605-020

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90020-090

Country

Brazil

Individual Site Status

Terminated

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

22793-080

Country

Brazil

Individual Site Status

Terminated

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01236-030

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01509-900

Country

Brazil

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

05403-010

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

01308-050

Country

Brazil

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Plovdiv

Country

Bulgaria

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100191

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Changchun

ZIP/Postal Code

130021

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Chongqing

ZIP/Postal Code

400037

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Fuzhou

ZIP/Postal Code

350001

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510100

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Haikou

ZIP/Postal Code

570311

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nanchang

ZIP/Postal Code

330006

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shengyang

ZIP/Postal Code

110004

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shenyang

ZIP/Postal Code

110001

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Shenzhen

ZIP/Postal Code

518039

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Urumchi

ZIP/Postal Code

830054

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wenzhou

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Xian

ZIP/Postal Code

710061

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Name

Research Site

City

Zhongshan

ZIP/Postal Code

528403

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Research Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Plzen

ZIP/Postal Code

304 60

Country

Czechia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Praha

Country

Czechia

Individual Site Status

Terminated

Facility Name

Research Site

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Montpellier Cedex 5

ZIP/Postal Code

34090

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75015

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Rennes Cedex 9

ZIP/Postal Code

35033

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Rouen Cedex 1

ZIP/Postal Code

76038

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Villejuif

ZIP/Postal Code

94800

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Köln

ZIP/Postal Code

50924

Country

Germany

Individual Site Status

Recruiting

Facility Name

Research Site

City

Paderborn

ZIP/Postal Code

33098

Country

Germany

Individual Site Status

Completed

Facility Name

Research Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

31999

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Jerusalem

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Petah Tiqva

ZIP/Postal Code

49100

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Tel Hashomer

ZIP/Postal Code

52620

Country

Israel

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Meldola

ZIP/Postal Code

47014

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20162

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Ravenna

ZIP/Postal Code

48121

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Individual Site Status

Terminated

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Terminated

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

D.F

ZIP/Postal Code

14050

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

01710

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64570

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Morelia

ZIP/Postal Code

58260

Country

Mexico

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Almere

ZIP/Postal Code

1315 RA

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Den Bosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Brzozów

ZIP/Postal Code

36-200

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Krakow

ZIP/Postal Code

30-727

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

50-367

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

50-556

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

93-510

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197347

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Saint-Petersburg

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Sochi

ZIP/Postal Code

354057

Country

Russian Federation

Individual Site Status

Completed

Facility Name

Research Site

City

St Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Tula

ZIP/Postal Code

300053

Country

Russian Federation

Individual Site Status

Completed

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Dammam

ZIP/Postal Code

31444

Country

Saudi Arabia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Jeddah

ZIP/Postal Code

21423

Country

Saudi Arabia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Riyadh

ZIP/Postal Code

12713

Country

Saudi Arabia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Riyadh

ZIP/Postal Code

14611

Country

Saudi Arabia

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

83310

Country

Slovakia

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

2013

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0044

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Randburg

ZIP/Postal Code

2125

Country

South Africa

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Badalona(Barcelona)

ZIP/Postal Code

08916

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Terminated

Facility Name

Research Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Individual Site Status

Terminated

Facility Name

Research Site

City

Göteborg

ZIP/Postal Code

41345

Country

Sweden

Individual Site Status

Completed

Facility Name

Research Site

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Örebro

ZIP/Postal Code

70185

Country

Sweden

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Individual Site Status

Terminated

Facility Name

Research Site

City

Tainan City

ZIP/Postal Code

70403

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Terminated

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Ankara

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Kurupelit

ZIP/Postal Code

55139

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Talas

ZIP/Postal Code

38280

Country

Turkey

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Ivano-Frankivsk

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Kharkiv Region

ZIP/Postal Code

61070

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Khmelnytskyi

ZIP/Postal Code

29000

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03022

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Kyiv

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Canterbury

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Individual Site Status

Active, not recruiting

Facility Name

Research Site

City

Wolverhampton

ZIP/Postal Code

WV10 OQP

Country

United Kingdom

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

34534514

Citation

Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.

Results Reference

derived

PubMed Identifier

33796237

Citation

Gordon MJ, Danilov AV. The evolving role of Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia. Ther Adv Hematol. 2021 Jan 30;12:2040620721989588. doi: 10.1177/2040620721989588. eCollection 2021.

Results Reference

derived

Learn more about this trial

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

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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

Chronic Lymphocytic Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial