A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (NCT06928376) | Clinical Trial Compass
RecruitingPhase 2
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients
China160 participantsStarted 2024-04-18
Plain-language summary
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).
Who can participate
Age range14 Years – 75 Years
SexALL
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Inclusion Criteria:
Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution
Exclusion Criteria:
Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)
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What they're measuring
1
Composite Complete Remission (CRc) Rate after 1 course of treatment