acute myeloid leukemia
Conditions
Interventions
therapy group:Immune cell therapy
Sponsors
Xiang'an Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Selection criteria: Only those who meet all of the following selected items can be included in this trial: 1) Patients with definite cytology, immunology, molecular biology, cytogenetics and pathology evidence, who are diagnosed with acute myeloid leukemia; 2) Male or female, aged 18-60 years old; 3) The expected survival period is >= 3 months; 4) Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form, with good compliance. 5) The main organs function normally, that is, they meet the following standards: 6) Blood routine: HB >= 60g/L (no blood transfusion or erythropoietin (EPO) dependency within 14 days); ANC >= 1.5 x 10^9/L; PLT >= 50 x 10^9/L; 7) Blood biochemistry: TBIL = 60ml/min; 9) Urine routine examination urine protein is less than 2+, or 24-hour urine protein quantitative = the lower limit of normal (50%).
Exclusion criteria
Exclusion criteria: Exclusion criteria (subjects with any of the following purposes will not be included in the study): 1) Those who are less than 18 years old or more than 60 years old; 2) Have received biological therapy, targeted therapy, immunotherapy and other anti-tumor therapy within 4 weeks before using the research drug for the first time; 3) Have received other clinical trial treatments within 4 weeks before using the study drug for the first time; 4) Received major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before using the study drug for the first time; 5) Unstable central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence showing that central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judges it is not suitable for inclusion; 6) Other uncontrolled active infections; 7) Have a history of immunodeficiency, including HIV antibody test positive; 8) Active hepatitis B (hepatitis B virus titer is higher than the lower limit of detection or need antiviral treatment), or hepatitis C virus (HCV) infection; 9) Severe cardiovascular disease: ventricular arrhythmia requiring clinical intervention; QTc interval > 480ms; acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events above grade III within 6 months ; New York Heart Association (NYHA) new function classification >= Grade II or left ventricular ejection fraction (LVEF) < 50%; uncontrollable hypertension. 10) Patients with active, or have had autoimmune diseases that have the possibility of recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); patients with clinically stable autoimmune thyroiditis are excluded . 11) People with mental disorders or poor compliance; 12) Women during pregnancy or lactation; 13) The researcher believes that the subject has other serious systemic diseases or other reasons and is not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow function status; | — |
Secondary
| Measure | Time frame |
|---|---|
| ECOG score; | — |
Countries
China
Contacts
Public ContactChen Tao
Xiang'an Hospital Affiliated to Xiamen University
Outcome results
None listed