Overview
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.
Description
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.
A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups:
Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support.
Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine.
The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.
The main goal of the study is to evaluate and compare the effectiveness of these two regimens in treating acute monocytic leukemia. Outcomes will include treatment response, safety, and overall patient outcomes during the study period.
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).
