CACAG+VEN: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
1. Azacytidine (75 mg/m2/day, days 1 to 7).
2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5).
3. Aclacinomycin (20 mg/day, days 1,3,5).
4. Chidamide (30 mg/day , days 1,4,8,11).
5. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery.
3+7: IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Study 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
Sex
ALL
Min age
14 Years
Max age
60 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
Composite Complete Remission Rate — At the end of Cycle 2 (each cycle is 28 days) Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC \<1.0×10⁹/L) or thrombocytopenia (platelets \<100×10⁹/L).
Trial sites (3)
Facility
City
Region
Status
Air Force Medical Center, PLA
Beijing
China
Recruiting
Chinese PLA General Hospital
Beijing
China
Recruiting
PLA Strategic Support Force's Characteristic Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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