Acute myeloid leukemia
Conditions
Interventions
trial group:One of the following treatment: (1) PD - 200 mg 1 inhibitors d1, every 4 weeks
Venetoclax 0.1/d d1, 0.2/d d2, 0.2/d d3-28 (reduced to 21 days at investigator's discretion), azacitidine 75mg/m2 d1-10 (reduced to 7 days at investigator's discretion) every 4 weeks
or
2) PD-1 inhibitor 200mg d1, every 4 weeks
Venetoclax 0.1/d d1, 0.2/d d2, 0.2/d d3-28 (reduced to 21 days at investigator's discretion), decitabine 20mg/m2 d1-7 (reduced to 5 days at investigator's discretion) every 4 weeks
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: A. For de novo AML, induction of AML that did not achieve CR after one or more cycles; Patients with AML who had a relapse at any time after remission. B. Age 14-80 years old, regardless of gender or race; C. Physical status: ECOG score 0-3; D. heart function: left ventricular ejection fraction is greater than or equal to 40%; E. Expected survival time > 12 weeks; F. Serum creatinine (Cr) =1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN, total bilirubin =1.5×ULN; G. The patient is self-aware and able to sign informed consent; The guardian of the child patient agreed to sign an informed consent form.
Exclusion criteria
Exclusion criteria: A. the thyroid function hyperfunction or impairment of patients, the combining immune bowel disease patients and merge rheumatism system disease patients; B. conducted other clinical trials within two weeks; C. Pregnant or lactating women; D. active HBV and HCV infection; E. People living with HIV;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse effects; | — |
Countries
China
Contacts
Public ContactJuan Tong
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