Spots Global Cancer Trial Database for Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia
Study ID: NCT04075292
Conditions
Study Description
Brief Summary: This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Detailed Description: Patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (Arm A) or rituximab in combination with chlorambucil (Arm B). The primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, , Taiwan
Research Site, Hualien City, , Taiwan
Research Site, Kaohsiung, , 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
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Lugui Qiu, MD
Affiliation: Chinese Academy of Medical Science Affiliated Hospital of Hematology
Role: PRINCIPAL_INVESTIGATOR
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