acute myeloid leukemia
Conditions
Interventions
Group A:Daunorubicin 60mg/m2/d, qd, intravenously, d1-d3, cytarabine 100mg/ m2/d, qd, intravenously or subcutaneously, divided twice, separated by 12h, d1-d7, Venecola 100mg d4, 200mg d5, 400mg d6-d11
Group B:Daunorubicin 60mg/ m2/d, intravenous injection, qd, d1-3
Ara-c 100mg/ m2/d was injected intravenously, qd or subcutaneously, divided into two times, separated by 12h, d1 ~ d7
Sponsors
The First Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Patients with newly diagnosed primary AML. The diagnostic criteria refer to 2016 WHO classification. 2.Patients aged 18 to 60 years; 3.Eastern Oncology Collaboration (ECOG) was 0-2 (see appendix 1); 4.Patients with LVEF >= 45% by echocardiography; 5.Patients with renal function creatinine clearance rate >= 50ml / min (calculated according to Cockcroft Gault formula or detected by 24-hour urine sample); 6.Liver function of aspartate aminotransferase (AST) <= 2.5xuln *; Alanine aminotransferase (ALT) <=2.5xULN*; Total bilirubin <=1.5xULN* (* unless thought to be due to leukemic infiltration); 7.Obtain informed consent signed by the patient or family member.
Exclusion criteria
Exclusion criteria: 1.Patients with acute promyelocytic leukemia (APL); 2.Patients who have received anthracycline pretreatment; 3.Patients with AML known to involve the central nervous system (CNS); 4.Known HIV infected subjects (due to possible drug drug drug interaction between antiretroviral drugs and venetoclax). HIV testing will be conducted at screening in accordance with local guidelines or agency standards; 5.Subjects with known positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Inactive hepatitis carriers or subjects with low viral titer after non prohibited antiviral therapy were not excluded; 6.Subjects who received potent or moderate CYP3A inducers / inhibitors within 7 days prior to the start of study treatment; 7.Subjects with NYHA cardiovascular disability grade > 2. Level 2 is defined as the patient's heart disease without conscious symptoms at rest, but fatigue, palpitation, dyspnea or angina pectoris may occur under normal physical activity; 8.Subjects with chronic respiratory diseases requiring continuous oxygen inhalation; 9.Patients who are unable to take drugs orally or with malabsorption syndrome; 10.Patients with uncontrolled systemic infection (viral, bacterial or fungal); 11.Subjects who were previously treated with venetoclax and / or who were currently involved in any other study of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (hematological and non-hematological adverse reactions);Overall survival;Event-free survival; | — |
Countries
China
Contacts
Public ContactZhu Honghu
The First Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed