Acute myeloid leukemia
Conditions
Interventions
Group of venetoclax combined with chemotherapy:Oral venetoclax
Group of chemotherapy:Without venetoclax
Sponsors
Handan Central Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Acute myeloid leukemia other than APL that met the diagnostic criteria of the Franco-Anglo-American collaboration group (FAB criteria); 2. Patients with acute myeloid leukemia other than APL WHO meet world Health Organization diagnostic criteria (WHO criteria); 3. AML without advanced MDS and/or MPD with multi-lineage pathological hematopoietic in accordance with WHO criteria; 4. Except for acute total myeloid hyperplasia with myelofibrosis and myeloid sarcoma, who classification of AML is not classified separately; 5. Older than 16 years old and younger than 55 years old, male or female; 6. The physical status assessment (ECOG-PS) of the Eastern Oncology collaboration group was 0-2; 7. Requirements for passing the following laboratory indicators (performed within 7 days prior to treatment): (1) Total bilirubin <= 1.5 times the upper limit of normal value (same age); (2) AST and ALT<= 2.5 times the upper limit of normal value (same age); (3) serum creatinine < 2 times the upper limit of normal (same age); (4) cardiac enzymes < 2 times the upper limit of normal value; (5) Echocardiography (ECHO) determined that cardiac ejection fraction was within the normal range. 8. Informed consent must be signed before the commencement of all specific study procedures, and informed consent must be signed by the patients themselves or their immediate family members if they are 18 years old or older; Informed consent signed by legal guardian for children and adolescents under the age of 18. Considering the patient's condition, if the patient's signature is not conducive to treatment, the informed consent shall be signed by the legal guardian or the patient's immediate family member.
Exclusion criteria
Exclusion criteria: 1. Relapse patients (those who have previously received induction chemotherapy, regardless of efficacy); 2. Secondary leukemia (mainly those WHO belong to the treatment-related AML subclass of the WORLD Health Organization (WHO) classification and have a history of MDS and/or MPD); 3. Patients with other blood system diseases (such as hemophilia and myelofibrosis, etc., considered by researchers as not suitable candidates; MDS and MPD patients with previous hematologic abnormalities, except previous bone marrow examination, were admitted); 4. Patients suffering from malignant tumors of other organs (requiring treatment); 5. Pregnant or nursing women. Female subjects of reproductive age must have a negative pregnancy test within 7 days of the start of the trial. Male or female participants must use contraception during the trial and for up to three years after completion of treatment; 6. Liver and kidney functions were obviously abnormal, exceeding the inclusion criteria; 7. Active heart disease, defined as one or more of the following: (1) A history of uncontrolled or symptomatic angina; (2) Myocardial infarction less than 6 months after enrollment; (3) A history of arrhythmia requiring medical treatment or severe clinical symptoms; (4) Uncontrolled or symptomatic congestive heart failure (higher than NYHA grade 2); (5) Ejection fraction is lower than the lower limit of the normal range. 8. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis); 9. Those considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Countries
China
Contacts
Public ContactXiaohui Suo
Handan Central Hospital
Outcome results
None listed