acute myeloid leukemia
Conditions
Interventions
Experimental group :the combination of decitabine, GM-CSF, and PD-1 inhibitor
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be at least 65 years old; Expected survival time =4 months; 2. Newly treated PATIENTS with AML (non-APL) were confirmed according to WHO (2016) AML diagnostic criteria by bone marrow examination, cytogenetics and other tests; 3. Have not received any previous anti-AML treatment such as chemotherapy, demethylation drugs, targeted therapy, or cellular immunity; 4. ECOG score is 0-2; 5. Creatinine =1.5*ULN; ALT=1.5*ULN, AST=1.5*ULN, total bilirubin =1.5*ULN, alkaline phosphatase =2.5*ULN; 7. Ecg and echocardiogram examination were normal, and the heart was not functional. 8. The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) or other anti-cancer treatments within 2 weeks before signing the informed consent; 9. Patients and their legal clients sign informed consent before treatment, which should inform them of all relevant clinical trial contents, patients' willingness and compliance with treatment plan, follow-up plan, laboratory examination, etc.
Exclusion criteria
Exclusion criteria: Subjects will not be randomly enrolled if they meet any of the following criteria: 1. Known allergy to drugs and their components in this study, and history of severe allergy to biological products (including antibiotics); 2. The presence of other serious diseases, such as serious impairment of important organ functions: respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.; 3. Severe autoimmune diseases; 4. Have an active viral or bacterial infection that is not controlled with appropriate anti-infective therapy; 5. Infectious diseases (such as HIV, active tuberculosis, etc.); 6. Active hepatitis B or C infection; 7. Complications of other neoplasms except superficial bladder cancer, basal or squamous cell carcinoma of the skin, cervical intraepithelial canceration (CIN), "in situ" breast cancer, or prostate intraepithelial canceration (PIN); Or other local malignancies with a high probability of cure after surgical resection or radiotherapy; 8. Those who are in clinical trials of other drugs; 9. Suffering from mental disorders or other medical conditions that cannot comply with the requirements of research treatment and testing; 10. There are other conditions that the investigator considers inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total response rate (ORR);Progression-free survival time (PFS);Overall survival rate(OS);Event free survival; | — |
Countries
China
Contacts
Public ContactZenlin Li
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed