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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03836261
Registration number
NCT03836261
Ethics application status
Date submitted
6/02/2019
Date registered
11/02/2019
Date last updated
29/05/2024
Titles & IDs
Public title
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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Scientific 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 (AMPLIFY)
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Secondary ID [1]
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0
D8221C00001
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Secondary ID [2]
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ACE-CL-311
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Universal Trial Number (UTN)
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Trial acronym
AMPLIFY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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0
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Venetoclax
Treatment: Drugs - Chemoimmunotherapy
Treatment: Drugs - Obinutuzumab
Experimental: Acalabrutinib, Venetoclax - Acalabrutinib in combination with Venetoclax
Experimental: Acalabrutinib, Venetoclax, Obinutuzumab - Acalabrutinib in combination with Venetoclax with Obinutuzumab
Active comparator: Chemoimmunotherapy - Chemoimmunotherapy
FCR: Fludarabine, Cyclophosphamide and Rituximab
BR: Bendamustine and Rituximab
Treatment: Drugs: Acalabrutinib
Acalabrutinib,
Treatment: Drugs: Venetoclax
Venetoclax
Treatment: Drugs: Chemoimmunotherapy
fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
Treatment: Drugs: Obinutuzumab
Obinutuzumab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS
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Assessment method [1]
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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
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Timepoint [1]
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6 years
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Secondary outcome [1]
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To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS
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Assessment method [1]
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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
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Timepoint [1]
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6 years
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Secondary outcome [2]
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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.
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Assessment method [2]
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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
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Timepoint [2]
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6 years
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/01/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
984
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Recruitment in Australia
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Research Site - Adelaide
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5000 - Adelaide
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2010 - Darlinghurst
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3084 - Heidelberg
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2217 - Kogarah
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3000 - Melbourne
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6009 - Nedlands
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2298 - Waratah
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4102 - Woolloongabba
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Recruitment outside Australia
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Taiwan
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State/province [122]
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Taichung
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Country [123]
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Taiwan
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State/province [123]
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Tainan City
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Country [124]
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Taiwan
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State/province [124]
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Taipei
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Country [125]
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Taiwan
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State/province [125]
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Taoyuan City
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Country [126]
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Turkey
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State/province [126]
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Ankara
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Country [127]
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Turkey
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State/province [127]
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Izmir
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Country [128]
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Turkey
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State/province [128]
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Kurupelit
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Country [129]
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Turkey
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State/province [129]
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Talas
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Country [130]
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United Kingdom
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State/province [130]
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Cambridge
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Country [131]
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United Kingdom
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State/province [131]
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Canterbury
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Country [132]
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United Kingdom
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State/province [132]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Acerta Pharma BV
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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AstraZeneca
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Address [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT03836261
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
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Jennifer Brown
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Dana Farber Mass General Brigham Cancer Care Inc
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03836261
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