Newly diagnosed patient acute myeloid leukemia with RUNX1 / RUNX1TI, CBFB/MYH11 mutation
Conditions
Interventions
Treatment group:Venetoclax in combination with high dose of Decitabine and Homoharringtonine (DEC3-VEN-HHT) as therapy
Sponsors
Tai'an City Central Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the World Health Organization diagnostic criteria (WHO2022 criteria) and are accompanied by t(8; 21)/(RUNX1/RUNX1TI), inv(16)(p13.1q22), t(16; 16) (p13.1q22), t(16; 16)/CBFß/myh11) patients with acute myeloid leukemia; 2. Patients with age >=16 years old, = 30 mL/min, calculated by Cockcroft Gault formula or measured by 24-hour urine collection; 6. Female fertile subjects must have negative pregnancy test results within 72 hours before the start of treatment; Pregnancy was not planned during the study period and for 6 months after the last administration of the study drug, and urine or serum pregnancy test results were negative at the time of screening. Men must use latex condoms during any sexual contact with WOCBP, even if they have undergone a successful vasectomy, and must agree to abstain from fertility (during treatment and within 6 months after the last administration of the study drug); 7. Expected survival time >= 2 months; 8. Informed consent must be signed before the start of all specific research procedures, and the informed consent must be signed by the patient or his immediate family; Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Exclusion criteria
Exclusion criteria: 1. AML was not accompanied by RUNX1/RUNX1TI, CBFB/MYH11); 2. Treated patients (Patients have previously received induction chemotherapy, regardless of efficacy); 3. secondary leukemia (Treatment-related AML subclass according to the World Health Organization (WHO 2016) AML classification and a history of preexisting MDS and/or MPD); 4. Patients have other blood system diseases (Researchers considered patients with hemophilia, myelofibrosis, those were not suitable for admission. Patients with previous blood abnormalities, but MDS and MPD were excluded from bone marrow examination. 5. Pregnant or lactating patients; 6. Allergy to any drug involved in this study; 7. Excessive or moderate use of CYP7A inducers within 3 days before the start of study therapy; 8, Suffering from other organ malignancies (need treatment); 9. Liver and kidney function were significantly abnormal, exceeding the inclusion criteria; 10. Active heart disease, defined as one or more of the following: (1) Myocardial infarction less than 6 months after enrollment; (2) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; (3) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); (4) Uncontrolled or symptomatic angina; (5) Left ventricular ejection fraction was lower than the lower limit of normal range; 11. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis), known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; Treating uncontrollable subjects. 12. Subjects with evidence of central nervous system leukemia before treatment; 13. Subjects with epilepsy, dementia, or other abnormal mental states that require medication and are unable to understand or follow protocols; 14. Restriction of oral drug intake or gastrointestinal absorption; 15. Those who are not considered suitable for inclusion by researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Complete response with incomplete blood count recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Minimal residual disease;Relapse free survival;Cumulative relapse frequencies; | — |
Countries
China
Contacts
Public ContactBai Guanchen
Tai'an City Central Hospital
Outcome results
None listed