Acute myeloid leukemia
Conditions
Interventions
trial group:Sintilimab combined with Azacytidine or Decitabine
Sponsors
Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. For the newly treated AML, the patients with two or more courses of standard regimen failed to achieve CR; the patients with the first recurrence used the standard regimen or the second-line regimen for induction chemotherapy for one course or more, and the AML patients with two or more relapses did not reach CR. 2. They are 14-80 years old, regardless of gender or race; 3. Physical condition: ECoG score was 0-3; 4. Cardiac function: left ventricular ejection fraction is greater than or equal to 40%; 5. The expected survival time was more than 12 weeks; 6. Serum creatinine (CR) <= 1.5 * ULN (upper limit of normal value), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 * ULN, total bilirubin <= 1.5 * ULN; 7. The patient has self-knowledge ability and can sign the informed consent; the guardian of the child patient agrees to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with hyperthyroidism or hypothyroidism, patients with immune bowel disease and patients with rheumatic diseases; 2. Other clinical trials were conducted within two weeks; 3. Pregnant or lactating women; 4. Active HBV or HCV infection; 5. HIV infected persons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median survival time; | — |
Countries
China
Contacts
Public ContactChangcheng Zheng
Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Outcome results
None listed