Acute myeloid leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 and above; 2. Patients with AML who were insensitive to at least 2 cycles of induction chemotherapy or who relapsed early after remission of previous treatment or who received reinduction therapy at late relapse without remission; 3. ECGO physical condition score 0-2, or KPS score greater than 60; 4. The patient has not taken other cytotoxic drugs (other than hydroxyurea) within 2 weeks or has completed 5 half-lives since last taking the tested drug or non-cytotoxic drug; 5. Serum aspartate aminotransferase and alanine aminotransferase were lower than 2.5 times the upper limit of normal; 6. The total amount of serum bilirubin was lower than 1.5 times the upper limit of normal; 7. Serum creatinine below 1.5 times the upper normal limit or estimated glomerular filtration rate above 50 mL/min; 8. Voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. Critically ill patients with acute promyelocytic leukemia or chronic myelogenous leukemia; 2. Uncontrolled infection of the patient, immunodeficiency virus infection or hepatitis B, hepatitis C or other liver damage diseases; 3. Active stage malignancies that are not myelodysplastic syndromes or AML; 4. Patients with persistent non-hematologic toxicity grade greater than 2 who developed symptoms before treatment with AML; 5. Patients who have received hematopoietic stem cell transplantation for less than 2 months or suffer from graft-versus-host disease requiring treatment, and non-hematologic toxicity greater than or equal to grade 2 after transplantation; 6. Diffuse intravascular coagulation disorder; 7. Received major surgery or radiation therapy within 4 weeks before the study began; 8. Serious heart disease: including but not limited to unstable angina pectoris, myocardial infarction, severe arrhythmia, and congestive heart failure class 3-4 according to the New York Heart Association (NYHA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completely remission;Partial mitigation;Overall response rate;Negative rate of tiny residual lesions;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Countries
China