Acute Myeloid Leukemia
Conditions
Interventions
CAV regimen group:NA
Sponsors
Chinese people's liberation army Northern Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years old; 2. According to the Chinese guidelines for the diagnosis and treatment of relapsed/refractory acute myeloid leukemia (2023), in accordance with the diagnosis and treatment of relapsed/refractory AML; 3. The diagnostic criteria of relapsed AML: the presence of leukemia cells in peripheral blood or blasts in bone marrow = 5% (excluding other reasons such as bone marrow regrowth after consolidation chemotherapy) or extramedullary leukemia cell infiltration after complete remission (CR) of AML; 4. Refractory AML diagnostic criteria: newly diagnosed patients who failed to response to two courses of standard treatment; Patients who relapsed within 12 months after consolidation and intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia. 5. Newly diagnosed AML other than APL confirmed by clinical diagnosis 6. ECOG PS =2; 7. Renal function: creatinine clearance =30ml/min; 8. Liver function: ALT < 5 times normal value, bilirubin < 3 times normal value; 9. Life expectancy =3 months; 10. Able to understand and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. cardiac function < grade 2; 2. Human immunodeficiency virus (HIV) infection; 3. Other clinically significant uncontrolled conditions including but not limited to: (1) uncontrolled or active systemic infection (viral, bacterial or fungal); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; ? Secondary tumors requiring active treatment; 4. Allergy to experimental drugs; 5. Pregnant and lactating women; 6. Patients deemed by the investigator to be ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD negative rate;Overall survival;Event free survival;Treatment related mortality;Adverse events; | — |
Countries
China
Contacts
Public ContactLiu Jinghua
Chinese people's liberation army Northern Theater Command General Hospital
Outcome results
None listed