acute myeloid leukemia
Conditions
Interventions
azacytidine plus venetoclax:azacytidine plus venetoclax
azacytidine plus placebo:azacytidine plus placebo
Sponsors
The first affiliated hospital of Anhui Medical University north distrct
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to understand the procedures and methods of this clinical trial, with sufficient informed consent, the subjects voluntarily participate and sign an informed consent form, fully understand and comply with the requirements of the trial protocol, and are willing to complete the study as planned; 2. When signing the informed consent form, age>=14 years old, regardless of gender; 3. The subject has AML (in accordance with WHO's diagnostic criteria in 2016) and is a first-time patient; 4. The expected survival time is greater than 3 months; Eastern Cancer Collaborative Group Physical Fitness (ECOG) score<=2 points (screening period); 5. Women of childbearing age must have a negative serum pregnancy test before enrollment and agree to take effective contraceptive measures during and within 6 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Those who are known or suspected to be allergic to the investigational drug or any component of azacytidine; 2. Those who have received treatment with cytarabine at or below the prescribed dose in the protocol and have developed intolerable toxicity; 3. History of illness and surgery: (1) Patients diagnosed as acute promyelocytic leukemia or with BCR-ABL positive leukemia (chronic myeloid leukemia blast), myeloid sarcoma or extramedullary leukemia; (2) Having a history of other malignant tumors (excluding AML), excluding curable cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma, or any other tumors that have been cured (with no evidence of disease recurrence within 5 years); (3) Individuals with hypertension who cannot achieve good control through medication treatment (resting state, systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg); Individuals who suffer from any of the following diseases within 12 months prior to administration: myocardial infarction, severe or unstable angina, coronary artery bypass grafting or peripheral artery bypass grafting surgery, congestive heart failure, cerebrovascular events (including transient ischemic attacks), etc; (4) There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); (5) Patients with a clear tendency for gastrointestinal bleeding include the following: locally active ulcer lesions with occult blood in stool (>=++); Individuals with a history of black stools and hematemesis within 2 months; Researchers believe that there may be significant gastrointestinal bleeding; (6) Have a history of immune deficiency, or suffer from other acquired or congenital immune deficiency diseases, with a history of organ transplantation; (7) Researchers or applicants who believe that they have other acute, severe or chronic medical or psychological conditions and are not suitable to participate in clinical trials; (8) Currently suffering from mental illness, obvious mental disorders or epilepsy; Patients without behavioral or cognitive abilities; (9) Screening patients who underwent major surgical procedures within the first 3 months; 4. Previous treatment history: (1) 4 weeks before starting administration or=20 × 109/L (2) Abnormal liver function: ALT and/or AST>=2.5 × ULN, serum total bil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactMingzhen Yang
The first affiliated hospital of Anhui Medical University north distrct
Outcome results
None listed