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

Launched by CHINESE PLA GENERAL HOSPITAL · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for patients who have just been diagnosed with acute myeloid leukemia (AML), a type of blood cancer. The trial aims to compare the traditional treatment method known as "3+7" with a newer combination treatment that includes a drug called venetoclax along with another treatment called CACAG. The goal is to find out which option is more effective and safer for patients with intermediate- or high-risk AML.

To participate in this trial, patients need to be between the ages of 14 and 75 and must have been newly diagnosed with AML (not of the M3 type). They should have normal liver and kidney function and must not have any uncontrolled infections or severe mental illnesses. If eligible, participants can expect to receive one of the two treatment regimens and will be closely monitored throughout the study. It’s important to note that patients who are pregnant, breastfeeding, or have certain allergies or health conditions may not be able to join the trial. This study is currently looking for volunteers, so it’s a great opportunity for those seeking treatment options.

Gender

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Eligibility criteria

• 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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