Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Chinese PLA General Hospital
200 participants
Aug 1, 2023
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.
Eligibility
Inclusion Criteria8
- Patients who are able to understand and willing to sign the informed consent form (ICF).
- All patients should aged 14 to 75 years,no gender limitation.
- Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria
- Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
- Renal function: creatinine ≤the upper limit of normal;
- Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
- The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
- Patients without severe allergic constitution.
Exclusion Criteria7
- Patients with allergy or contraindication to the study drug;
- Female patients who are pregnant or breast-feeding.
- Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
- Patients with mental illness or other states unable to comply with the protocol;
- Less than 6 weeks after surgical operation of important organs.
- Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin>2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
- The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
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Interventions
1. Azacytidine (75mg/m2/day, days 1 to 7). 2. Cytarabine (75-100mg/m2 q12h, days 1 to 5). 3. Aclacinomycin(20mg/day, days 1,3,5). 4. Chidamide(30mg/day , days 1,4,8,11). 5. Venetoclax (100mg on day 1,200mg on day 2,400mg on days 3-14). 6. Granulocyte colony stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)
1. FLAG regimen:Fludarabine(30mg/m2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5) 2. CLAG regimen:Cladribine(5mg/2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to 5) 3. MAE regimen:Mitox(10mg/m2,days 1 to 5)+VP-16(100mg/m2,days 1 to 5)+Cytarabine (100-150mg/m2,days 1 to 7) 4. DCAG regimen:Decitabine(20mg/m2,days 1 to 5)+Aclacinomycin(20mg/day on days 1,3,5)+Cytarabine (100mg q12h,days 1 to 5)+Granulocyte colony-stimulating factor(300 ug/day,day 0 until agranulocytosi recovery) 5. HAA regimen:HHT(2mg/m2,days 1 to 7)+Aclacinomycin(20mg/day,days 1 to 7) and Cytarabine (100-200 mg/m2, days 1 to 5); 6. HAD regimen:HHT(2mg/m2,days 1 to 7)+Daunorubicin(45mg/m2/day,days 1 to 3)+Cytarabine (100-200 mg/m2,days 1 to 5).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06084819