acute myeloid leukemia
Conditions
Interventions
Treatment group:1.VEN: 400mg daily orally or 100mg daily (combined with azole antifungals) orally d1-14
2.decitabine: 20mg/m2 d1-5
3.cytarabine:50mg-75mg/m2 q12h d1-d5
4.aclarubicin:20mg d1-5
5.G-CSF:300ug/d or polyethylene glycol long-acting colony-stimulating factor (PEG-CSF) 6mg once a week.
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
10 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients with AML (not AML-M3) diagnosed according to the 2016 World Health Organization (WHO) diagnostic criteria for myeloid malignant diseases; 2) Patients with no remission or relapse after remission after at least one prior systemic therapy (including chemotherapy, hematopoietic stem cell transplantation, etc.); 3) ECOG behavioral status score of 0-3; 4) Expected survival time = 3 months; 5) Weight: 67±20 kg (47-87 kg) for men and 55±20 kg (35-75 kg) for women; 6) No serious cardiac, pulmonary, hepatic or renal diseases;
Exclusion criteria
Exclusion criteria: 1) Patients who do not meet the diagnostic criteria for relapsed/refractory acute myeloid leukemia; 2) patients who use drugs or chronic alcohol abuse to such an extent that it interferes with the evaluation of the test results; 3) patients with psychiatric or other conditions that prevent them from obtaining informed consent and from cooperating with the requirements for completing the treatment and examination steps of the trial; 4) Patients with a history of clinically significant QTc interval prolongation (>450ms in men and >470ms in women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block of degree II or greater, myocardial infarction within 1 year of the onset of myocardial infarction (MI), congestive heart failure (CHF), and coronary artery disease with symptoms requiring pharmacological treatment; 5) Patients with a cardiac ultrasound showing end-diastolic pericardial cavity fluid dark area = 10 mm in width; 6) Hypomelanosis with leukocytes 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or ALT/AST > 5 times the upper limit of normal in patients with hepatic invasion) and abnormal renal function (serum creatinine > 1.5 times the upper limit of normal); 8) Those who are judged by the investigator to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission (CR) Rate;partial remission (PR) rate;overall response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurable Residual Disease (MRD) negative remission rate;Overall Survival (OS);progression-free survival(PFS); | — |
Countries
China
Contacts
Public ContactYu Jing
Chinese PLA General Hospital
Outcome results
None listed