Spots Global Cancer Trial Database for A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia
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Trial Identification
Brief Title: A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia
Official Title: An International, Multicenter, Randomized, Double-blind, Phase 3, Pivotal Registration Clinical Study of APG-2575 (Lisaftoclax) in Combination With Azacytidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Study ID: NCT06389292
Conditions
Study Description
Brief Summary: An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.
Detailed Description: The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group (Lisaftoclax+ AZA) or the control group (placebo+ AZA).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hematology Hospital of the Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
Name: Jianxiang Wang, M.D.
Affiliation: Hematology Hospital of the Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Jie Jin, M.D.
Affiliation: Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
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