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A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

StatusRecruiting
PhasePhase 2
Started2024-04-18
View on ClinicalTrials.gov ↗

Amendment history

2026-05-04
Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations v3
Trial status changed: Active, Not Recruiting → Recruiting
Study sitesdetails revised at 1 of 1 site
Collaborators7 to 6 entries
Chinese People's Liberation Army Air Force General Hospital
2026-03-18
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-04-18→confirmed 2025-09-01
Completion date2026-10-18→2026-09-01
Study sitesdetails revised at 1 of 1 site
2025-04-20
Study Status, Eligibility v1
Eligibility criteria-270 characters
Inclusion Criteria: All patients should agedAge 14 to75to 75 years, (no gender limitation. Patients) who are newlyNewly diagnosed with intermediate- or high-risk AML (noexcluding M3). Liver function: ALT and AST ≤ 2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤the upper limit of normal; Patients without anyNo uncontrolled infections, without organ dysfunction, or without severe mental illness; TheECOG performance status score of Eastern Cooperative Oncology Group (ECOG) is 0-3,2 and the pr [...] [...]
2025-04-14
Original filing
The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).
Trial Details
NCT Number NCT06928376
Lead Sponsor Chinese PLA General Hospital
Collaborators: First Affiliated Hospital of Harbin Medical University, Yantai Yuhuangding Hospital, The General Hospital of Western Theater Command, 940 Hospital of the People's Liberation Army Joint Logistic Support Force, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Jining First People's Hospital
Conditions Acute Myeloid Leukemia, First Line Therapy
Enrollment 160 participants
Start Date 2024-04-18
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-08