Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia

Summary

This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.

Eligibility

Inclusion Criteria:

* Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
* Age 14 to 60 years at screening, no gender restriction.
* Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
* No history of severe allergic reactions.
* Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.
* Renal function: serum creatinine ≤ 1.5 × ULN
* No uncontrolled infection or severe psychiatric disorder.
* ECOG performance status 0-3; life expectancy ≥ 4 months.

Exclusion Criteria:

* Known hypersensitivity or contraindication to any study drug.
* Pregnancy or lactation.
* Active infection.
* Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
* Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
* Major organ surgery within 6 weeks prior to enrollment.
* Abnormal liver function: total bilirubin \> 2× ULN, ALT/AST \> 2.5 × ULN; abnormal renal function: serum creatinine \> 1.5 × ULN.
* Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).

Conditions2

Interventions2

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