Acute Myeloid Leukemia
Conditions
Sponsors
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acute myeloid leukemia (AML) who have clinically confirmed molecular relapse after transplantation and have failed first-line treatment or refused to use first-line drugs: 1.1 Molecular recurrence definition: (1) AML patients without specific fusion or mutant gene markers: AML co-expressing genes WT1 and (or) FCM are often used as biological markers for MRD detection. 1) WT1 test was positive for 2 consecutive times (=0.6%), and the interval was 5-7d; 2) Two consecutive positive FCM tests (=0.1%) with an interval of 5-7 days; 3) Both FCM and WT1 were positive. (2) Leukemia with specific genetic mutations or fusion genes: RT-qPCR was used to detect molecular markers closely related to leukemia load and recurrence with a sensitivity of 0.01%. 1) If it is accompanied by AML1-ETO, CBFß-MYH11 and NPM1, MRD > 0.01% is considered positive 18, 19. 2) If there is FLT3-ITD, FLT3-TKD, C-KIT, NRAS/KRAS, IDH1 and IDH2 gene mutation, the mutant/wild type allele ratio > 3% is considered to be positive. 1.2 Definition of first-line treatment failure: 1) MRD continued to be positive after the use of azacytidine/decitabine, Venecola, and other first-line drugs; 2) MRD still changed from Yin to Yang after the use of first-line drugs; 3) Patients who cannot tolerate azacitidine/decitabine, Venecola, and other first-line drugs; 2. Age 18-60 years old; 3. No serious damage to the function of major organs of the whole body; 4. No history of drug allergy: 5. Subjects who plan to become pregnant must agree to use contraception before entering the study and after the study lasts for six months; Notify the investigator immediately if the subject is pregnant or suspected to be pregnant; 6. The subject understands and signs the informed consent;
Exclusion criteria
Exclusion criteria: 1. 60 years old; 2. There are basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, renal function, gastrointestinal insufficiency, etc 3. Clinically uncontrolled active infections (including bacterial, fungal, or viral infections) that do not respond to medical treatment; 4. Degree III-IV GVHD 5. Are participating in other clinical studies, or plan to start this study treatment less than 4 weeks from the end of the previous clinical study treatment 6. Patients with other malignant tumors requiring treatment; 7. Have a history of allergy to the drugs in the program 8. Female subjects are pregnant and lactating; 9. Human immunodeficiency virus (HIV) infection or syphilis infection; 10. Active hepatitis that remains uncontrolled after active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid [HBV DNA] or hepatitis C virus RNA [HCV RNA]); 11. Persistent COVID-19 positive patients (excluding positive patients who have turned negative); 12. Situations that the investigator believes may increase the risk to the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Relapse free survival; | — |
Countries
China
Contacts
Public ContactDonghua Zhang
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed