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Trial record 16 of 19 for:    Venetoclax AND Bendamustine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836261
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

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

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

Detailed Description:

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

The study includes screening (30 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : April 30, 2024


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

Drug: Venetoclax
Venetoclax
Other Name: Venclyxto, Venclexta

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

Drug: Venetoclax
Venetoclax
Other Name: Venclyxto, Venclexta

Drug: Obinutuzumab
Obinutuzumab
Other Name: Gazyva, Gazyvaro

Active Comparator: Chemoimmunotherapy

Chemoimmunotherapy

FCR: Fludarabine, Cyclophosphamide and Rituximab

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




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


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

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



Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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

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


Contacts
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Contact: CALL CENTER 1-888-292-9613 Acertamc@dlss.com

Locations
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United States, Kentucky
Research Site Recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02215
United States, New Jersey
Research Site Recruiting
Brick, New Jersey, United States, 08724
Research Site Recruiting
Florham Park, New Jersey, United States, 07932
Research Site Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Research Site Recruiting
Lake Success, New York, United States, 11042
United States, Ohio
Research Site Recruiting
Canton, Ohio, United States, 44718
United States, Pennsylvania
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Research Site Recruiting
Fort Sam Houston, Texas, United States, 78234
United States, Washington
Research Site Recruiting
Spokane, Washington, United States, 99208
Research Site Recruiting
Tacoma, Washington, United States, 98405
Australia, Victoria
Research Site Recruiting
Heidelberg, Victoria, Australia, 3084
Australia
Research Site Recruiting
Adelaide, Australia, 5000
Research Site Recruiting
Darlinghurst, Australia, NSW
Research Site Recruiting
East Melbourne, Australia, 3002
Research Site Recruiting
Kogarah, Australia, 2217
Research Site Recruiting
Perth, Australia, 6009
Research Site Recruiting
Waratah, Australia, 2298
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Woolloongabba, Australia, 4102
Austria
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Krems, Austria, 3500
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Salzberg, Austria, 5020
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Vienna, Austria, 1140
Bulgaria
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Vratsa, Bulgaria
Canada
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Calgary, Canada, T2N 2T9
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Edmonton, Canada, T6G1Z2
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Montréal, Canada, H4J 1C5
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Ottawa, Canada, K1H 8L6
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Québec, Canada, G1J1Z4
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Toronto, Canada, M5G 2M9
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Toronto, Canada
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Vancouver, Canada, V5Z 4E6
Czechia
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Brno, Czechia, 62500
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Hradec Králové, Czechia, 500 05
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Olomouc, Czechia, 77900
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Ostrava, Czechia, 70852
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Pilsen, Czechia, 30460
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Praha, Czechia, 100 34
Israel
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Haifa, Israel, 3109610
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Jerusalem, Israel, 9103102
Research Site Recruiting
Jerusalem, Israel, 91120
Research Site Recruiting
Petah Tikvah, Israel, 49100
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Ramat-Gan, Israel, 5265601
Research Site Recruiting
Tel Aviv, Israel, 64239
Italy
Research Site Recruiting
Milano, Italy, 20132
Research Site Recruiting
Milan, Italy, 20162
Research Site Recruiting
Ravenna, Italy, 48121
Korea, Republic of
Research Site Recruiting
Incheon, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03080
Research Site Recruiting
Seoul, Korea, Republic of, 6591
Research Site Recruiting
Seoul, Korea, Republic of
Poland
Research Site Recruiting
Kraków, Poland, 30-510
Research Site Recruiting
Wojnicz, Poland, 36-200
Russian Federation
Research Site Recruiting
Moscow, Russian Federation, 125284
Research Site Recruiting
Saint Petersburg, Russian Federation, 191024
Research Site Recruiting
Saint Petersburg, Russian Federation, 197341
Research Site Recruiting
Samara, Russian Federation, 443095
Research Site Suspended
Tula, Russian Federation, 300053
Research Site Recruiting
Volgograd, Russian Federation
Saudi Arabia
Research Site Recruiting
Dammam, Saudi Arabia, 51215
Slovakia
Research Site Recruiting
Bratislava, Slovakia
South Africa
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Bloemfontein, South Africa, 09301
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Johannesburg, South Africa, 1709
Research Site Recruiting
Pretoria, South Africa, 0181
Spain
Research Site Recruiting
Majadahonda, Madrid, Spain, 28222
Research Site Recruiting
Barcelona, Spain, 08035
Research Site Recruiting
Madrid, Spain, 28007
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Madrid, Spain, 28031
Research Site Recruiting
Santander, Spain, 39008
Sweden
Research Site Recruiting
Örebro, Sweden, 70217
Taiwan
Research Site Recruiting
Taichung, Taiwan, 40447
Research Site Recruiting
Taipei, Taiwan, 112
Turkey
Research Site Recruiting
Ankara, Turkey, 06500
Research Site Recruiting
Ankara, Turkey, 06
Research Site Recruiting
İzmir, Turkey, 35340
United Kingdom
Research Site Recruiting
Canterbury, United Kingdom, CT1 3NG
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT03836261    
Other Study ID Numbers: ACE-CL-311
D8221C00001 ( Other Identifier: AstraZeneca )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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