Acute myeloid leukemia (AML)
Conditions
Interventions
Experimental group:VHAA regimen (HHT 2mg/m2/d, qd, intramuscular injection, d1~d5
cytarabine 100mg/m2/d, q12h, subcutaneous injection, d1~d5, aclarithromycin 12mg/m2/d, Intravenous injection, d1~d5, venetoclax 100mg d2, 200mg d3, 300mg d4~d10, qd, oral)
Sponsors
First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Primary and secondary AML patients. The diagnostic criteria refer to the 2016 WHO classification. 2. Aged 18-60 years. 3. Eastern Cooperative Oncology Group (ECOG) score of 0-2. 4. Cardiac ultrasound LVEF>=45%. 5. Renal function creatinine clearance rate >= 50mL/min (calculated according to Cockcroft Gault formula or detected by 24-hour urine sample). 6. Liver function aspartate aminotransferase (AST) <= 2.5 x ULN*; alanine aminotransferase (ALT) <= 2.5 x ULN*; total bilirubin <= 1.5 x ULN* (*unless thought to be due to leukemic infiltration).
Exclusion criteria
Exclusion criteria: 1. Subjects who have received anthracycline pretreatment. 2. Subjects with AML known to involve the central nervous system (CNS). 3. Subjects known to be HIV-infected (due to possible drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be performed at screening, as required by local guidelines or agency standards. 4. Subjects known to be positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Inactive hepatitis carriers or subjects with viral hepatitis virus titers below the detection value (10^3) after treatment with non-prohibited antiviral drugs were not excluded. 5. Subjects receiving treatment with a strong or moderate CYP3A inducer/inhibitor within 7 days prior to initiation of study treatment. 6. Subjects manifested as New York Heart Association Cardiovascular Disability Status Class > 2. Grade 2 is defined as a patient with cardiac disease that is asymptomatic at rest, but can experience fatigue, palpitations, dyspnea, or angina with ordinary physical activity. 7. The subject has chronic respiratory disease that requires continuous oxygen inhalation. 8. Subjects with inability to take oral medication or malabsorption syndrome. 9. The presence of an uncontrolled systemic infection (viral, bacterial or fungal). 10. Previous treatment with venetoclax and/or current participation in any other study of the investigational drug. 11. Unable to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite complete remission rate after one or two cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;hematological and non-hematological adverse reactions;measurable residual disease;disease free survival;different biological characteristics of response and non-response patients explored through single-cell sequencing;the difference of intestinal microbiota between response and non-response patients; | — |
Countries
China
Contacts
Public ContactJin Jie
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed