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

Recruiting now · Phase 2

Conditions studied: Acute Monocytic Leukemia

In brief

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.

Key facts

Study ID

NCT07512700

Run by

Chinese PLA General Hospital

People needed

204

Starts

2025-09-01

Expected to finish

2029-10-31

Last updated by the study team

2026-04-06

Who can join

Age: 14 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Air Force Medical Center, PLA — Beijing, China (enrolling)
• Chinese PLA General Hospital — Beijing, China (enrolling)
• PLA Strategic Support Force's Characteristic Medical Center — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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