A Phase 2 interventional study of Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor and "3+7" in Acute Myeloid Leukemia, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 14 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Chinese PLA General Hospital · Phase 2, Interventional, and Treatment
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's enrollment of 200 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
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Patients who are able to understand and willing to sign the informed consent form (ICF).
Exclusion Criteria:
Venetoclax combined with CACAG regimen for newly diagnosed AML. Recipients were randomized and those entering the experimental group received azacytidine, cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg/m2/day from day 1 to day 7. Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5. Chidamide was used as 30 mg/day on days 1,4,8,11. Venetoclax was used as 400 mg/day from day 1 to day 14;Combined with posaconazole, reduced to 100 mg/day;Combined with voriconazole, reduced to 200 mg/day.Granulocyte colony-stimulating factor was used as 300 μg/day from day 0 until agranulocytosi recovery .
Drug: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
Idarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.
Drug: "3+7"
1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 bid, 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 (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ). 6. Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
Also known as: CACAG+VEN
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.
Also known as: IA or DA
Overall Response Rate (ORR) after 1 course of treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR) or CR with incomplete blood count recovery (CRi).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
Time frame: 1 months after the start of study treatment
Complete Remission (CR) Rate after 1 course of treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts\<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame: 2 months after study treatment
Complete Remission (CR) Rate after 2 courses of treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts\<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame: after two courses of chemotherapy (each course is 28 days)
Overall Response Rate (ORR) after 2 course of treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR) or CR with incomplete blood count recovery (CRi).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
Time frame: after two courses of chemotherapy (each course is 28 days)
Rate of Minimal Residual Disease (MRD)-Negative Response
Percentage of participants who achieved MRD-negative response, defined as \< 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry.
Time frame: after two courses of chemotherapy (each course is 28 days)
Event-free survival
Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.
Time frame: 180 days after study treatment
Overall Survival (OS)
Defined as the time from joining the clinical study to death due to any cause.
Time frame: 180 days after study treatment
Treatment-related adverse events
Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.
Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment
Early death
Defined as death within 30 days of chemotherapy.
Time frame: Within 30 days of the start of the first course of treatment
Disease-free survival
Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.
Time frame: 180 days after study treatment
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital