Acute myeloid leukemia
Conditions
Interventions
experimental group:SKLB1028
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients who voluntarily participated in the study and signed the informed consent; 2. Male or female Chinese patients, aged >= 18 years; 3. The pathological and morphological diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to the classification of World Health Organization (who) in 2016; 4. Subjects with refractory or relapsed AML after first-line AML treatment (with or without HSCT). (1) Patients with AML who were refractory after first-line treatment (see Appendix 1 for details) were defined as: no Cr / CRI / CRP after initial treatment. Subjects who are suitable for standard treatment must have received at least one cycle of induction therapy with standard dose of anthracycline (2017 Chinese guidelines for diagnosis and treatment of relapsed / refractory AML). According to the evaluation of the researchers, the subjects who do not meet the standard treatment must have received the best induction therapy for at least one complete treatment cycle; (2) Early relapse after first-line treatment was defined as: relapse after Cr / CRI / CRP = 30 ml / min. 9. Subjects who can take the test drug orally; 10. Female / male subjects of childbearing age should take adequate non drug contraceptive measures from the time of signing the informed consent until 180 days after the last administration, and should not donate sperm or eggs.
Exclusion criteria
Exclusion criteria: 1. Patients with acute promyelocytic leukemia (APL) or bcr-abl positive leukemia (chronic myeloid leukemia blasts). 2. Patients with AML secondary to chemotherapy or radiotherapy for other tumors (except MDS) were diagnosed; 3. AML patients with central nervous system involvement (defined as patients with highly suspected central nervous system involvement and supported by imaging evidence); 4. Patients with refractory hypokalemia or hypomagnesemia who are not easy to correct after symptomatic treatment and have had recurrent episodes in the past; 5. Patients with graft-versus-host disease (GVHD) of clinical significance or receiving systemic corticosteroids for GVHD; 6. Patients with previous history of other malignant tumors (except for the following cases: Patients with disease-free status for more than 5 years; non melanoma skin cancer, cervical cancer or breast cancer in situ [regardless of disease status]; localized prostate cancer without recurrence or progression after radiotherapy or surgery, etc.); 7. Patients with clinically significant coagulation abnormalities in screening stage, such as disseminated intravascular coagulation (DIC), hemophilia A A, hemophilia B, and von Willebrand disease; 8. Patients who had undergone major surgery for major organs within 4 weeks before entering the study (the definition of major surgery refers to the level 3 and level 4 surgery specified in the administrative measures for clinical application of medical technology, see Appendix 7); or have not fully recovered from any previous invasive operation; 9. Patients who had received radiotherapy within 4 weeks before entering the study; 10. Patients with NYHA grade 3 or 4 congestive heart failure, or who had a history of NYHA grade 3 or 4 congestive heart failure, were not allowed to participate in the study unless the left ventricular ejection fraction (LVEF) >= 45% was detected by echocardiography within one month before entering the study (see Appendix 8 for NYHA grade); 11. In patients with bradycardia, the heart rate is less than 50 beats / min, except for those who use pacemaker; 12. The mean value of QT interval (QTCF) corrected by fridericia formula was > 450 ms in male and > 470 MS in female; 13. Patients with long QT syndrome diagnosed or suspected in screening stage (including family history of long QT syndrome); 14. Patients with second degree (mobita II) or third degree atrioventricular block (except those using pacemakers); 15. Patients with history of uncontrollable angina or myocardial infarction in the first 6 months were screened; 16. Patients with complete left bundle branch block in screening stage; 17. Patients with clinically significant arrhythmias (except for sinus tachycardia caused by anemia, infection and AML) or subjects with previous arrhythmias who need to take drugs that may prolong QT interval for a long time; 18. Patients with active or uncontrollable infection; 19. Patients with HBsAg positive or history of hepatitis B and HBV-DNA >= 2000 IU/ml in recent 3 months; patients with hepatitis C antibody positive and HCV-RNA positive in recent 3 months; 20. Patients with positive anti HIV antibody or anti Treponema pallidum specific antibody; 21. Before taking the test drug, the time from the end of the last AML treatment: cytotoxic chemotherapy drugs < 2 weeks, or non cytotoxic drugs < 5 half lives (except hydroxyurea and other treatments used to control leukocytosis); 22. Subjects who had taken s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR/CRh; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DOR; | — |
Countries
China
Contacts
Public ContactLiu Ting
West China Hospital of Sichuan University
Outcome results
None listed