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Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia

StatusRecruiting
PhasePhase 3
Started2024-11-18
View on ClinicalTrials.gov ↗

Amendment history

2026-08-19
Study Identification, Study Status, Sponsor/Collaborators, Study Design v2
Phase changed: Phase 2 → Phase 3
Collaborators4 to 8 entries
Fourth Medical Center of PLA General Hospital The First Medical Center of Chinese PLA General Hospital The 306 Hospital of People's Liberation Army Air Force General Hospital of the PLA
2026-06-11
Study Status v1
Primary completion moved earlier: 2027-12-30 → 2027-09-30
2026-03-31
Original filing
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
Trial Details
NCT Number NCT07514936
Lead Sponsor Chinese PLA General Hospital
Collaborators: 940 Hospital of the People's Liberation Army Joint Logistic Support Force, The General Hospital of Western Theater Command, First Affiliated Hospital of Harbin Medical University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Fourth Medical Center of PLA General Hospital, The First Medical Center of Chinese PLA General Hospital, The 306 Hospital of People's Liberation Army, Air Force General Hospital of the PLA
Conditions Newly Diagnosed Acute Myeloid Leukemia (AML), Elderly Patients
Enrollment 120 participants
Start Date 2024-11-18
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20