Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia
About this study
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.
- Condition
- Acute Monocytic Leukemia
- Tested
- CACAG+VEN, 3+7
- Sponsor
- Chinese PLA General Hospital
Who can join
- Age
- 14 to 60 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 14 years
- Maximum age: 60 years
- Study condition: Acute Monocytic Leukemia
- 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 8
- 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
3 sites, 3 recruiting
Air Force Medical Center, PLA
Beijing, China
Chinese PLA General Hospital
Beijing, China
PLA Strategic Support Force's Characteristic Medical Center
Beijing, China
Contact
-
Liping Dou, Doctor
+8613681207138 lipingruirui@163.com
-
Daihong Liu, Doctor
+8613681171597 daihongrm@163.com
Potential match only. Final eligibility is determined by the study team.