Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT04075292
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
155 participants
INTERVENTIONAL
2020-01-20
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity
Acalabrutinib
acalabrutinib 100 mg twice daily orally
Rituximab and Chlorambucil
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles
Rituximab
Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
Chlorambucil
Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
Interventions
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Acalabrutinib
acalabrutinib 100 mg twice daily orally
Rituximab
Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
Chlorambucil
Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status of 0, 1, or 2
* Diagnosis of CLL that meets published diagnostic criteria (Hallek 2018)
* Active disease per IWCLL 2018 criteria that requires treatment
* Adequate bone marrow function
* Adequate renal and hepatic function
Exclusion Criteria
* Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (eg, Richter's transformation, PLL, or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia
* History of prior malignancy except for the following: (a) Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment
* Significant cardiovascular disease
* Known history of infection with human immunodeficiency virus (HIV)
* Serologic status reflecting active hepatitis B or C infection
* Any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
* Major surgical procedure within 30 days of first dose of study drug
* Any prior CLL-specific therapies
* Corticosteroid use \>20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
* For women only: breastfeeding or pregnant
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lugui Qiu, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Science Affiliated Hospital of Hematology
Locations
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Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Changzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guiyang, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Qingdao, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Shijiazhuang, , China
Research Site
Suzhou, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Xuzhou, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Research Site
Baguio City, , Philippines
Research Site
Cebu, , Philippines
Research Site
Davao City, , Philippines
Research Site
Makati, , Philippines
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Chiayi City, , Taiwan
Research Site
Hualien City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Bangkok, , Thailand
Research Site
Chiang Mai, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Khon Kaen, , Thailand
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D822BC00001
Identifier Type: -
Identifier Source: org_study_id
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